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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Phototherapy (e.g., ultraviolet A [UVA], ultraviolet B [UVB], or psoralen plus UVA [PUVA]) alone or combined with other agents is proven for the treatment of vitiligo. The evidence suggests that narrowband UVB and PUVA are the most effective types of phototherapy for treating vitiligo.

Narrowband or ultra narrowband UVB laser or excimer laser are proven for the treatment of vitiligo.

All other forms of laser treatment (not listed above as proven) are unproven for the treatment of vitiligo. Additional, larger studies are needed to validate the effectiveness of other types of laser therapy for treating vitiligo and to determine the optimal dosing and administration method for other types of laser therapy.

Several states mandate coverage for laser therapy for treatment of port-wine stains and cutaneous Benefit hemangiomata under certain circumstances. As in all benefit adjudication, federal and state legislated Considerations mandates must be followed. Therefore, the applicable state-specific requirements and the enrolleespecific benefit document must be reviewed to determine what benefits, if any, exist for laser therapy for treatment of port-wine stains and cutaneous hemangiomata.

Regulatory Requirements

U.S. Food and Drug Administration (FDA):

Phototherapy: A number of different phototherapy devices have been approved by the FDA. These include devices that deliver blue, green, and yellow light phototherapy; photothermolysis devices, intense pulsed dye lasers, and near-infrared

lasers. See the following Web site for more information (use product codes FTC or GEX):

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed February 2009.

Ultraviolet (UV) lights for dermatological treatment are regulated by the FDA as Class II devices and over 200 of these lights have been approved via the FDA 510(k) process. For some conditions, surgical lasers are used to provide the UV light.

These lasers are also regulated as Class II devices and many surgical lasers have been approved via the FDA 510(k) process.

See the following Web site for more information [use Product Code FTC (dermatological ultraviolet light) or GEX (powered

surgical laser instrument)]:

http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=PMA&id=15216. Accessed February 2009.

See the following Web site for information on the drug psoralen (methoxsalen) which is used in PUVA:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. (Type: methoxsalen; then continue clicking on the drug name to access all available documents). Accessed February 2009.

Photodynamic Therapy: The FDA has given approval for marketing to both Levulan Kerastick and the BLU-U(TM) Blue Light Photodynamic Therapy Illuminator on December 3, 1999 as components of a two-step therapy for the treatment of nonhyperkeratotic actinic keratoses (AK) of the face or scalp. Treated lesions that have not completely resolved after 8

weeks may be treated a second time. See the following Web site for more information:

http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed February 2009.

Metvix or Metvixia received marketing approval from the FDA in 2004 for the treatment of nonhyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation in the Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline physician's office when other therapies are unacceptable or considered medically less appropriate. See the following Web

site for more information:

http://www.accessdata.fda.gov/scripts/cder/ drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed February 2009.

Laser Therapy: Several flashlamp-pumped pulsed dye lasers (FLDPLs), Xenon-chloride (XeCl) excimer lasers, and erbium:yttrium-aluminum-garnet (Er:YAG) lasers have received FDA approval. See the following Web site for more

information (use product code GEX):

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed February 2009.

Pulsed Dye Laser (PDL): PDLs are classified as Class II devices. In 1986, the Candela Corporation manufactured the first PDL approved by the FDA for the treatment of cutaneous vascular lesions. Since then, various models have been developed and deemed substantially equivalent by the FDA. See the following Web site for more information: See the following Web

site for more information (use product code GEX):

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed February 2009.

Research Evidence Background Light therapy which includes artificial light sources such as phototherapy, photodynamic therapy, and various lasers is used to treat a variety of skin conditions, including the following: acne vulgaris, Actinic Keratoses (AK), Atopic Dermatitis, Cutaneous vascular lesions (port wine stains and hemangiomata), hidradenitis, psoriasis, rosacea, and vitiligo.

Light therapy for the treatment of skin conditions includes the following techniques:

- Phototherapy: Phototherapy is defined as exposure to nonionizing radiation for therapeutic benefit. It can include the use of visible light, photodynamic therapy, photothermolysis, and laser therapy. More specifically, visible light phototherapy utilizes ultraviolet-free light within the visible spectrum, such as blue and red visible light with wavelengths spanning 415 to 660 nm. Ultraviolet A (UVA) phototherapy uses long-wave radiation (340 to 400 nm) and can be administered as low, medium, or high dose. Ultraviolet B (UVB) uses wavelengths of 290 to 320 nm, and narrowband UVB only 311 to 313 nm.





Narrowband UVB phototherapy produces greater clearing with a lower likelihood of sunburn-type reactions and a lower risk of skin cancer compared with conventional broad-band UVB. To enhance the effectiveness of UV radiation, a combination with topical or systemic agents may be used. A photochemotherapeutic agent such as psoralen may be administered orally or topically. This combined therapy, is also known as photochemotherapy, or PUVA (psoralen plus ultraviolet A). Patients with severe or disabling psoriasis may undergo concentrated treatment with UVB and topical coal tar also known as the Goeckerman regimen. Another type of phototherapy is photothermolysis which used both light and heat energy with broadband intense pulsed light (IPL). IPL systems utilize high intensity, polychromatic pulsed light sources that emit noncoherent, polychromatic light from yellow to infrared (550 to 1400 nm). IPL systems target multiple chromophores, such as water, melanin, and hemoglobin, while sparing surrounding tissue, by means of selective photothermolysis. Phototherapy with the 308-nanometer (nm) wavelength xenon chloride (XeCl) excimer laser is known as excimer laser therapy (ELT).

- Photodynamic Therapy (PDT): PDT consists of a two-step process which involves: (1) application of a topical photosensitizing solution of 5-aminolevulinic acid (ALA, brand name Levulan® Kerastick®lesion; and (2) exposure to a light source. Light therapy has been administered after a 3- to 48-hour application interval. Once applied, ALA and MAL are converted within the cells into protoporphyrin IX (PpIX), a potent photosensitizer. Cells containing PpIX are very susceptible to light-induced damage and, when the treated lesion is exposed to a light source, cells within the lesion are destroyed. One proposed advantage of ALA with PDT (ALA-PDT) or MAL with PDT (MAL-PDT) compared with other treatments is their ability to be applied more selectively, thus sparing the surrounding skin from iatrogenic damage.

Treatment is currently limited to treatment of nonhyperkeratotic lesions, due to ineffective penetration of photosensitizer in thicker lesions and the consequent lack of conversion to PpIX.

- Laser Therapy: Laser therapy has been investigated as an alternative to standard UVA or UVB phototherapy. Laser Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline treatment decreases the risk of complications, particularly sunburn-like reactions and skin cancer. Surgical lasers work by producing intense beams of virtually nondivergent light that can cut, seal, and vaporize abnormal skin tissues. A surgical laser emits one specific color, or wavelength, of light (monochromatic) that can be varied in its intensity and pulse. The laser can deliver high UVB doses in a small field at a narrow UVB band. The types of lasers used include the flashlamp-pumped pulsed dye laser (FLPDL) or pulsed dye laser (PDL), the xenon-chloride (XeCl) excimer laser, and the high-powered erbium:yttrium-aluminum-garnet (Er:YAG) laser, each of which exerts its therapeutic effects by different mechanisms.

Cryogen spray cooled PDL (CPDL) involves the application of a cryogen spurt to the skin surface milliseconds prior to laser irradiation. This cools the epidermis without affecting the deeper PWS blood vessels, and reduces the thermal injury sustained by the skin during laser treatment.

Research Evidence

Acne Vulgaris:

Visible Light Phototherapy: The largest trial evaluating the use of phototherapy with visible light for treatment of inflammatory acne lesions treated acne patients (n=107) with blue and red light, and determined the mean improvement in the number of inflammatory acne lesions from baseline was 76%, a significantly greater improvement in acne lesions than patients in the control groups. (Papageorgiou et al., 2000) A clinical trial included 45 patients who were treated with highintensity pure blue light. The treatment was well tolerated with 50% of the patients highly satisfied with the therapy results.

(Tremblay et al., 2006) Photodynamic Therapy: One randomized controlled trial evaluating the effectiveness of photodynamic therapy as an acne treatment reported that patients treated with multiple sessions of ALA and red light photodynamic therapy or ALA alone experienced significantly greater improvement in acne lesions than all groups who had single treatments. (Hongcharu et al.,

2000) In a comparative study, investigators studied the effect of ALA and photodynamic therapy and reported that patients treated with only blue light experienced a 25% improvement in acne severity, 40% decrease in papules, 65% decrease in pustules, and 62% decrease in comedones. Patients treated with ALA and photodynamic therapy experienced a 32% improvement in acne severity, 68% decrease in papules, 61% decrease in pustules, and 62% decrease in comedones.

(Goldman and Boyce, 2003) There were no comparative statistical analyses performed to evaluate the differences between the two treatment groups. A blinded randomized controlled trial of 21 patients concluded that MAL-PDT is an efficient treatment for inflammatory acne. However, MAL-PDT treatment was associated with severe pain and the development of severe erythema, pustular eruptions, and epithelial exfoliation. (Wiegell and Wulf, 2006a) Several other randomized controlled trials that were small in size found that PDT may be effective in the treatment of acne vulgaris. (Horfelt et al., 2006; Wiegell and Wulf, 2006b; Alexiades-Armenakas, 2006) Laser Therapy: Two small, randomized controlled trials of similar size reported conflicting results regarding the efficacy of pulsed dye laser therapy for facial acne. In one study, pulsed dye laser significantly improved inflammatory facial acne lesions after a single treatment in comparison with patients who underwent sham treatment. (Seaton et al., 2003) However, the authors of the second study reported that there were no significant differences between laser-treated and untreated skin.

(Orringer et al., 2004) A randomized controlled trial of 46 patients who received laser treatment with Nd:YAG laser to half of the face found a transient but significant improvement in lesion counts of open comedones in treated skin as compared with untreated skin. There was no significant difference between treated and untreated sides of the face for changes in mean papule or pustule counts (Orringer et al., 2007). A randomized controlled trial included 20 patients who received diode laser therapy. Significant improvement in acne lesion counts was noted and was maintained 12 months after treatment (Jih et al., 2006).

Sami et al., (2008) evaluated 45 patients with moderate to severe acne who were randomly divided into 3 groups. Group 1 received pulsed-dye laser (PDL). Group 2 received intense pulsed light (IPL). Group 3 received blue-red combination lightemitting diode (LED) phototherapy. The investigators concluded that phototherapy is a useful therapeutic option for treatment of moderate to severe acne, but further studies are needed to evaluate treatments with a larger number of patients and for a longer period of follow-up.

Haedersdal et al. (2008) conducted a systematic review of 16 randomized controlled trials (RCTs) and 3 controlled trials that Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline evaluated the safety and efficacy of different types of phototherapy for treatment of acne vulgaris. This analysis found that light treatments were effective for short term treatment of acne vulgaris with superior outcomes for PDT with up to 68% improvement with 5-aminolevulinic acid (ALA), methyl ester (MAL), and red light. Most studies were of suboptimal methodological quality due to lack of detail about the randomization methods, high drop-out rates, and lack of intention to treat analysis. The authors concluded that further research is needed to compare phototherapy with other treatments of acne vulgaris.

According to Hayes, the overall quality of evidence regarding phototherapy for acne vulgaris is moderate to weak. The limited number of studies, small sample sizes, variability in patient selection criteria, limited comparisons with standard therapies, differences in definitions of the severity of acne, limited comparison to standard therapies, and differences in treatment protocols among studies hampered comparison of results and made assessment of the true treatment effect of the various types of phototherapy difficult (Hayes, 2009).

American Academy of Dermatologists (AAD)/American Academy of Dermatological Association (AADA): In 2007, the AAD issued guidelines for the management of acne reporting that topical therapy and systemic antibiotics are a standard of care for the treatment of acne vulgaris. Although recommendations for different treatment options for acne vulgaris were defined, no specific treatment protocols for phototherapy as a treatment intervention for acne vulgaris were provided (Strauss et al., 2007).

American Society for Laser Medicine and Surgery (ASLMS): The ASLMS issued a statement noting that there are several treatment modalities, including mid infrared (1200-1800 nm) laser therapy, broadband blue light, intense pulsed light treatments, and laser-assisted photodynamic therapy, that have been shown to be clinically effective for treatment of acne, although none is considered a cure. The ASLMS supports continued study of various laser/light wavelengths and technologies as an alternative to daily drugs or creams (ASLMS, 2007).

Actinic Keratoses (AK):

Evidence provided by the available published studies indicates that treatment of AK with 5-aminolevulinic acid (ALA) photodynamic therapy (PDT) is effective, especially for head and neck lesions, and generally well tolerated. Complete response rates for lesions of the face and scalp ranged between 70% and 100%, with a lower response rate and fewer data reported for lesions of extremities and trunk. (Hayes Directory, 2004) The largest randomized, placebo-controlled study of

ALA-PDT enrolled a total of 243 patients with nonhyperkeratotic AK on the face or scalp. Patients were randomized in a 3:1

ratio to ALA solution or vehicle, and were exposed to a blue light illuminator for 1000 seconds. At 12 wks, 73% of patients receiving ALA had complete response of AK lesions, compared with 8% of patients receiving placebo. (Piacquadio et al.,

2004) Several studies have also demonstrated that methyl aminolevulinate photodynamic therapy (MAL-PDT) is effective and well-tolerated (Pariser et al., 2008; Morton et al., 2006).

A guidance report from the National Institute for Health and Clinical Excellence concluded that evidence supports the efficacy of PDT for AK (National Institute for Health and Clinical Excellence, 2006).

Atopic Dermatitis:

A randomized controlled trial performed by Reynolds et al. evaluated 73 patients with moderate to severe atopic dermatitis who were randomly assigned to narrow-band UVB (n=26), broad-band UVA (n=24), or visible fluorescent light (n=23).

Results showed significant benefit resulting from narrow-band UVB therapy, as compared with placebo. UVA therapy was also superior to placebo, although the difference was not statistically significant. The researchers felt the small sample size might not have allowed a small effect to be found (Reynolds et al., 2001).

In a study by de Kort and van Weelden (2000), the efficacy of topical (bath) psoralen plus ultraviolet A (PUVA) was evaluated in 35 patients with severe atopic dermatitis. Twenty-nine patients completed the study, showing an 82% improvement in lesion severity, 75% reduction in lesion extension, 74% improvement in itching, and 79% improvement in night-time rest.

Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline Evidence for use of laser therapy for atopic dermatitis is limited. A study evaluated the effectiveness of xenon chloride excimer laser for treating atopic dermatitis in 15 patients. The investigators found that there was improvement in atopic dermatitis severity after one month of treatment. (Baltas et al., 2006) The American Academy of Dermatology (AAD): AAD has published guidelines of care for atopic dermatitis. (Hanifin et al.,

2004) The guidelines are based literature searches from 1990 to June 2003. The evidence was graded as to its quality and, of the nine included studies for phototherapy and atopic dermatitis, three were deemed to be Level I (well-designed randomized comparative or controlled trials): Krutmann et al. (1998); von Kobyletzki et al. (1999); and Reynolds et al. (2001). The guidelines are not specific in their advice regarding phototherapy and atopic dermatitis although they do state, "most patients in these studies experienced substantial improvement in symptoms, and use of topical corticosteroids was significantly reduced. Several studies involving PUVA combined with topical corticosteroids demonstrated substantial improvement."

(Hanifin et al., 2004)

Cutaneous Vascular Lesions (Port-Wine Stains [PWS] and Hemangiomata):

There is sufficient evidence to support the use of pulsed dye laser (PDL) therapy in patients with PWS who require definitive treatment to alleviate or prevent medical or psychological complications. (Hayes Directory, Pulsed Dye Laser Therapy for Cutaneous Vascular Lesions, 2006) Results from the reviewed studies indicate that PDL therapy for PWS can produce a better blanching response with fewer side effects than either the copper vapor laser or the argon-pumped continuous-wave dye laser. (Sheehan-Dare and Cotterill, 1994; Dover et al., 1995; Edstrom et al., 2002) There is also sufficient evidence to support the use of PDL therapy for treatment of superficial hemangiomas or the superficial component of mixed hemangiomas in patients requiring definitive treatment to alleviate or prevent medical or psychological complications. (Hayes Directory, Pulsed Dye Laser Therapy for Cutaneous Vascular Lesions, 2006) One reasonably well-designed randomized controlled trial evaluating the efficacy of 585 nm PDL in infants found that early PDL treatment of uncomplicated hemangiomas was no better than a wait-and-see policy, and may even increase the risk of skin atrophy and hypopigmentation. (Batta et al., 2002) In contrast, evidence from lesser quality studies suggests that PDL therapy can induce involution, prevent enlargement, or eliminate cutaneous hemangiomas in selected cases. (Chang et al., 2001; Raulin and Greve, 2001; Hohenleutner et al., 2001) None of the deep hemangiomas or the deep components of mixed hemangiomas responded to PDL therapy. The results from randomized controlled trials suggest that the hemangiomas that responded well in other studies may have resolved spontaneously without treatment, thereby obviating the need for putting an infant at risk of such adverse effects as pain, scarring, and skin pigment changes. However, this is balanced by the consideration that between 20% and 40% of children are left with residual skin changes, ranging from mild telangiectasia to permanent deformation of facial features, after spontaneous involution of hemangiomas. (Hohenleutner and Landthaler, 2002)

Hidradenitis:

The volume of published literature related to laser and photodynamic therapy for hidradenitis is low. A retrospective study evaluated 34 patients with hidradenitis suppurativa who underwent scanner-assisted carbon dioxide laser surgery. The mean follow-up time after laser surgery was 34.5 months. During follow-up, 4 patients had recurrences at the surgical site. Thirty patients had no recurrences in the treated area, but 12 patients developed de novo suppurating lesions within 5 cm of the initial surgical site. (Lapins et al., 2002) A case series of 4 patients with hidradenitis suppurativa underwent ALA-PDT, and clinical improvements from 75-100% were demonstrated. (Gold et al., 2004)

Psoriasis:

Feldman et al. enrolled 124 adult patients with stable, mild to moderate plaque psoriasis involving less than 10% of their body surface area in a study of excimer laser light of 308 nm. In this multicenter study, 72% of patients achieved 75% reduction in Psoriasis Area and Severity Index (PASI) score in an average of 6.2 treatments; 35% achieved 90% reduction in an average of 7.5 treatments. Side effects were significant in this study, as more than 50% of patients reported erythema and 45.2% reported blistering. (Feldman et al., 2002) Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline In a comparative study, 15 patients with psoriasis underwent excimer laser and narrowband UVB. Nine patients demonstrated more clearing with laser, 4 showed more clearing with narrowband UVB, and 2 showed no difference between treatments. (Goldinger et al, 2006) A randomized comparison of broadband UVB and narrowband UVB in 100 patients with psoriasis demonstrated similar efficacy between the 2 techniques. (Kirke et al., 2007) Another randomized controlled trial that included 1241 patients with psoriasis concluded that bath PUVA and saltwater UVB are comparable effective treatments and superior to tap water UVB and UVB alone. (Schiener et al., 2007) Yones et al. compared the efficacy of PUVA and narrowband UVB therapy in a double-blind randomized study and found that PUVA achieves clearance in more patients with longer remissions and fewer treatment sessions. (Yones et al., 2006) Pahlajani et al. (2005) compared the safety and efficacy of the 308-nm excimer laser in 18 adults and 7 children with localized mild-to-moderate plaque-type psoriasis. Both the children and the adult groups showed a significant decrease in psoriatic severity scores of their respective target lesions. The investigators concluded that the 308 nm excimer laser appears to be a safe and effective treatment for localized psoriasis in children as well as in adults.

The available studies investigating laser and phototherapy treatment for psoriasis are mainly limited to adult patients with localized chronic plaque psoriasis. There are currently minimal data on the efficacy and safety of laser and phototherapy therapy for patients with other types of psoriasis, with widespread disease, or with disease that responds to standard therapies.

The American Academy of Dermatology (AAD): AAD published a Guideline for Management of Psoriasis that states that UVB is safe and effective for the treatment of psoriasis. Narrow band (NB) UVB is more effective than broadband UVB. Up to 20 to 25 NB UVB treatments, given 2 to 3 times a week, may be required for significant improvement. The AAD guideline also indicates that PUVA therapy is very effective in the majority of patients with psoriasis, with potential for long remissions. However, long-term PUVA treatment is associated with an increased risk of squamous cell carcinoma and possibly malignant melanoma in Caucasians. PUVA induces photoaging and other skin changes including lentigines. NBUVB therapy avoids some of the adverse side effects of PUVA, while being slightly less effective than PUVA (Menter et al., 2008).

The AAD issued a consensus statement on psoriasis therapies that includes phototherapy (UVB with or without topicals or oral retinoids) and PUVA as treatment for moderate to severe psoriasis. Phototherapy may also be used for pustular psoriasis and guttate psoriasis. (Callen et al., 2003) Rosacea: Studies were selected for inclusion if they were prospective, evaluating any form of light or laser therapy for rosacea, and enrolling 20 or more patients. In addition, all controlled studies were eligible for review, regardless of number of enrolled subjects. Studies were not included if patients were treated for rhinophyma or ocular rosacea, or if the study also included patients who suffered from non-rosacea facial signs, such as non-rosacea telangiectasia.

Six studies met the inclusion criteria. (Clark et al., 2002; Taub, 2003; Lonne-Rahm et al., 2004; Tan et al., 2004; Schroeter et al., 2005; Uebelhoer et al., 2007) These studies ranged in size from 12 to 65 patients. All but two were prospective, nonrandomized studies without blinding or controls. Clark et al. (2002) conducted a controlled study using one cheek of each patient as the internal control. In a randomized, controlled, split-face study, Uebelhoer et al. (2007) compared the pulsed 532-nm potassium titanyl phosphate (KTP) laser and the 595-nm pulsed dye lasers PDL for the treatment of facial telangiectasias associated with rosacea or photoaging. Schroeter et al. (2005) randomly selected patients for inclusion into a prospective uncontrolled study.

In these relatively short-term studies, treatment with PDL and IPL generally resulted in varying degrees of improvement in rosacea symptoms, most notably reduction of facial telangiectases, flushing, and erythema, without producing sustained side Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline effects. Clearance rates for flushing, skin texture, redness, and telangiectases ranged from 50% to 87%, depending on the treatment location on the face. Only one study, conducted by Clark et al. (2002), reported statistically significant reductions in erythema, flushing, and telangiectasia scores. Treatment of papules and pustules associated with rosacea was evaluated in only one study, and results indicated that 64% of patients noted fewer papules or pustules (Taub et al., 2003). Schroeter et al.

(2005) reported more than 75% clearance of facial telangiectases, with clearance most notable on the forehead. The response was not correlated with any technical variables, such as pulse time, number of treatments, wavelength, or fluence. Lesion recurrence was observed in only 4 sites after 3 years following treatment. In the only randomized, blinded, comparative study, Uebelhoer et al. (2007) reported that the 532-nm KTP device was at least or more effective than the 595-nm PDL device. The KPL laser achieved 85% clearance of telangiectasia compared with 75% clearance with the PDL device, although no statistical analyses were reported.

The American Academy of Dermatology (AAD): The AAD does not have a clinical guideline on the treatment of rosacea.

However, according to a pamphlet published in the AAD Online Resource Center, treatment options for rosacea include laser surgery to close off the dilated blood vessels. (AAD, 2005)

Vitiligo:

PUVA Phototherapy: Ermis et al. (2001) and Cherif et al. (2003) found that PUVA combined with calcipotriol enhanced repigmentation, particularly during the early stages of treatment; however, Baysal et al.(2003) found that calcipotriol had no significant effect. Furthermore, the best outcome reported in these three studies was that 63% of patients achieved greater than 75% repigmentation of lesions after PUVA and calcipotriol treatment. (Ermis et al., 2001) UVA Phototherapy: Steroids, phenylalanine, and khellin have been used rather than psoralen as adjuncts to UVA phototherapy for vitiligo but only khellin seems likely to stimulate repigmentation by the same mechanism as psoralen.

Despite its structural similarity to psoralen, topical khellin was not found to improve UVA-induced repigmentation.

(Procaccini et al., 1995) Steroids work by a different mechanism than psoralen and a large, randomized comparative study (n=135) found that combined treatment with UVA and fluticasone was more effective than either treatment alone, providing an average repigmentation of 25% after 9 months of therapy. (Westerhof et al., 1999) UVB Phototherapy: Treatment of vitiligo with UVB has also been investigated as a method that may be safer and more effective than UVA-based protocols. In 3 small controlled studies, 1 to 6 months of UVB phototherapy was found to provide 18% to 68% of patients with greater than 75% repigmentation of treated lesions. (Hamzavi et al., 2004; Spencer et al., 2002) A double-blind randomized study included 56 patients with nonsegmental vitiligo who were randomly assigned to receive therapy with PUVA or narrowband UVB. At the end of therapy, 16 (64%) of 25 patients in the narrowband UVB group demonstrated 50% improvement in body surface area affected compared with 9 (36%) of 25 patients in the PUVA group.

(Yones et al., 2007) A systematic review of 7 studies (n = 305) on the therapeutic use of narrowband (NB) UVB phototherapy concluded that there is moderate evidence that NB UVB may be considered the first-choice treatment option for vitiligo. The investigators indicated that there is a lack of randomized controlled trials comparing NB UVB with broadband UVB and PUVA. Followup studies are needed to investigate the permanency of NB UVB-induced repigmentation. (Gambichler et al., 2005) Laser Therapy: According to Hayes, 2 small studies designed as within-patient comparisons provide evidence that excimer laser therapy is more efficacious than narrow-band ultraviolet B phototherapy for the treatment of vitiligo (Casacci et al., 2007; Hong et al., 2005). Excimer laser therapy increased the level of repigmentation in a greater percentage of patients (lesions) over a shorter period compared with standard therapy. The findings from these studies were supported by evidence from several other randomized controlled trials, nonrandomized controlled studies, and uncontrolled case series that evaluated excimer laser therapy alone or that compared the efficacy of excimer laser therapy for lesions that were treated with a topical medication or placebo. (Hadi et al., 2006; Shen et al., 2007) There is some evidence that adding a topical immunomodulator or vitamin D analog treatment to excimer laser therapy may improve the efficacy of excimer laser therapy Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline alone. However, larger trials that include comparisons of narrow-band ultraviolet B plus adjuvant topical medications with excimer laser therapy treatment arms that receive adjuvant therapy alone are needed to prove conclusively that combination therapy exerts additional clinical benefits.

There were no studies that provided substantial evidence that other types of laser therapy for treating vitiligo are effective.

American Academy of Dermatology (AAD): The AAD Web site contains a pamphlet that lists PUVA and narrowband UVB as repigmentation therapy for vitiligo. The AAD cautions that skin repigmentation with PUVA may require at least a year of twice weekly treatments and that treatment with PUVA has a 50 to 70% chance of returning color on the face, trunk, and upper legs and upper arms. Hands and feet respond poorly. The AAD mentions excimer lasers under the Other Treatment Options section, stating, "Excimer lasers may be tried as well". (AAD, 2005) Additional Medical Products Photodynamic therapy products include but are not limited to the following: BLU-U(TM) (DUSA Pharmaceuticals Inc, Wilmington, MA), Levulan® Kerastick® (DUSA Pharmaceuticals Inc, Wilmington, MA), Metvix® or Metvixia®(PhotoCure ASA, Oslo, Norway).

The following phototherapy devices are available for treatment of acne vulgaris. Blue Light: ClearLight Acne Photoclearing System (Lumenis, Santa Clara, CA), BLU-U 4170 (DUSA Pharmaceuticals, Wilmington, MA), OmniLux Blue (Phototherapeutics, Manchester, UK).

Green Light: 532 nm Aura Laser and 532/1064 nm Gemini laser (Laserscope, San Jose, CA). Intense Pulsed Light Sources:

ClearTouch (Radiancy Inc., Orangeburg, NY), Ellipse (DDD, Horsholm, Denmark), Estelux™System (ICN Photonics Ltd., Llanelli, UK). Near-infrared Lasers: Smoothbeam (Candela, Wayland, MA), CoolTouch CT3 (CoolTouch Inc., Roseville, CA), Aramis (Quantel, Clermont-Ferrand, France).

The complete list of commercially available devices for ultraviolet phototherapy is too extensive for inclusion here but includes ultraviolet lights made by manufacturers such as DELCOMp, Leuven, Belgium; MedTech Lighting Corp., Hudson Falls, NY; National Biological Corp., Twinsburg, OH; Philips Lighting Co., Utrecht, Netherlands; Sellamed, Gevelsberg, Germany; Photomed World Industries GMBH, Hamburg, Germany; UVBioTek, North Fort Myers, FL; and Waldmann Lighting, Villingen-Schwenningen, Germany.

Pulsed-dye lasers include but are not limited to the following: C-beam Pulse Dye Laser System (Candela Corp.);

PhotoGenica V Star and PhotoGenica V lasers (Cynosure, Inc.) Excimer laser devices include but are not limited to the following devices: Excilite® (Deka M.E.L.A.); XTRAC® Excimer Laser (PhotoMedex Inc.); 308 Excimer System (Quantel Derma); Talos Excimer Laser (Quantel Derma); PHAROS Excimer Laser EX-308 (RA Medical Systems Inc.) Additional Search Terms Aminolevulinic acid hydrochloride (ALA HCl), keratosis, protoporphyrin IX, photosensitizer, solar keratoses, atopy, balneotherapy, birth mark, chromophore, erythema, selective photothermolysis, yellow-light laser, Acne conglobata, acne mechanica, chloracne, erythrosis, glandular rosacea, granulomatous rosacea, hidradenitis, keloid, lupus erythematosus, macule, microcomedo, perioral dermatitis, perioral rosacea, photodermatitis, rosacea fulminans, seborrheic dermatitis, steroid acne, tinea faciei, nevus flammeus, capillary hemangiomas, 308-nanometer (nm) wavelength xenon chloride (XeCl) excimer laser

Definitions Protoporphyrin IXPpIX

Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline References and Resources Resources Alexiades-Armenakas M. Long-pulsed dye laser-mediated photodynamic therapy combined with topical therapy for mild to severe comedonal, inflammatory, or cystic acne. J Drugs Dermatol. 2006 Jan;5(1):45-55.

American Academy of Dermatology (AAD) [Web site] Public Resource Center. Rosacea. 2005. Available at:

http://www.aad.org/public/Publications/pamphlets/Rosacea.htm. Accessed February 2009.

American Academy of Dermatology (AAD) [Web site] Public Resource Center. Vitiligo. 2005. Available at:

http://www.aad.org/public/Publications/pamphlets/Vitiligo.htm. Accessed February 2009.

American Society for Laser Medicine and Surgery (ASLMS) Web site. Platform on laser/light treatment of acne. 2007.

Available at: http://aslms.org/news/platform.shtml. Accessed February 2009.

Baltas E, Csoma Z, Bodai L, et al. Treatment of atopic dermatitis with the xenon chloride excimer laser. J Eur Acad Dermatol Venereol. 2006 Jul;20(6):657-60.

Batta K, Goodyear HM, Moss C, et al. Randomised controlled study of early pulsed dye laser treatment of uncomplicated childhood haemangiomas: results of a 1-year analysis. Lancet. 2002;360(9332):521-527.

Baysal V, Yildirim M, Erel A, Kesici D. Is the combination of calcipotriol and PUVA effective in vitiligo? J Eur Acad Dermatol Venereol. 2003;17(3):299-302.

Belsito DV. Management of atopic dermatitis in the adult patient. Section 2: Diagnosis. Medscape Dermatology. 2005;6(1).

Medscape from WebMD [Web site]. Available at: http://www.medscape.com/viewarticle/504216_2. Accessed October 2007.

Callen JP, Krueger GG, Lebwohl M, McBurney EI, Mease P, Menter A, Paller AS,Pariser DM, Weinblatt M, Zimmerman G; AAD. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol. 2003 Nov;49(5):897-9.

Casacci M, Thomas P, Pacifico A, Bonnevalle A, Paro Vidolin A, Leone G. Comparison between 308-nm monochromatic excimer light and narrowband UVB phototherapy (311-313 nm) in the treatment of vitiligo--a multicentre controlled study. J Eur Acad Dermatol Venereol. 2007 Aug;21(7):956-63.

Chang CJ, Kelly KM, Nelson JS. Cryogen spray cooling and pulsed dye laser treatment of cutaneous hemangiomas. Ann Plast Surg. 2001;46(6):577-583.

Cherif F, Azaiz MI, Ben Hamida A, et al. Calcipotriol and PUVA as treatment for vitiligo. Dermatol Online J. 2003;9(5):4.

Choi KH, Park JH, Ro YS. Treatment of Vitiligo with 308-nm xenon-chloride excimer laser: therapeutic efficacy of different initial doses according to treatment areas. J Dermatol. 2004 Apr;31(4):284-92.

Clark SM, Lanigan SW, Marks R. Laser treatment of erythema and telangiectasia associated with rosacea. Lasers Med Sci.

2002;17(1):26-33.

de Kort WJ, van Weelden H. Bath psoralen-ultraviolet A therapy in atopic eczema. J Eur Acad Dermatol Venereol.

2000;14(3):172-174.

Dover JS, Geronemus R, Stern RS, et al. Dye laser treatment of port-wine stains: comparison of the continuous-wave dye laser with a robotized scanning device and the pulsed dye laser. J Am Acad Dermatol. 1995;32(2 pt 1):237-240.

Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline ECRI Institute. Custom Hotline Response. Blue Light Therapy for Acne. June 2007.ARCHIVED.

ECRI Institute. Custom Hotline Response. Laser Therapy for Acne. January 2009.

ECRI Institute. Custom Hotline Response. Laser Therapy for Eczema. December 2006. ARCHIVED.

ECRI Institute. Custom Hotline Response. Laser Therapy for Psoriasis. November 2008.

ECRI Institute. Custom Hotline Response. Laser Therapy for Rosacea. December 2006. ARCHIVED ECRI Institute. Photodynamic Therapy (PDT) with Aminolevulinic Acid for Treatment of Actinic Keratosis (AK) and Other Skin Lesions. August 2008.

EdstrDW, Hedblad MA, Ros AM. Flashlamp pulsed dye laser and argon-pumped dye laser in the treatment of port-wine stains: a clinical and histological comparison. Br J Dermatol. 2002;146(2):285-289.

Ermis O, Alpsoy E, Cetin L, Yilmaz E. Is the efficacy of psoralen plus ultraviolet A therapy for vitiligo enhanced by concurrent topical calcipotriol? A placebo-controlled double-blind study. Br J Dermatol. 2001;145(3):472-475.

Feldman SR, Mellen BG, Housman TS, et al. Efficacy of the 308-nm excimer laser for treatment of psoriasis: results of a multicenter study. J Am Acad Dermatol. 2002;46(6):900-906.

Gambichler T, Breuckmann F, Boms S, et al.. Narrowband UVB phototherapy in skin conditions beyond psoriasis. J Am Acad Dermatol. 2005 Apr;52(4):660-70.

Gold M, Bridges TM, Bradshaw VL, Boring M. ALA-PDT and blue light therapy for hidradenitis suppurativa. J Drugs Dermatol. 2004 Jan-Feb;3(1 Suppl):S32-5.

Goldinger SM, Dummer R, Schmid P,et al.. Excimer laser versus narrow-band UVB (311 nm) in the treatment of psoriasis vulgaris. Dermatology. 2006;213(2):134-9.

Goldman MP, Boyce SM. A single-center study of aminolevulinic acid and 417 NM photodynamic therapy in the treatment of moderate to severe acne vulgaris. J Drugs Dermatol. 2003;2(4):393-396.

Hadi S, Tinio P, Al-Ghaithi K, et al. Treatment of vitiligo using the 308-nm excimer laser. Photomed Laser Surg.

2006;24(3):354-357.

Hamzavi I, Jain H, McLean D, et al. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004;140(6):677-683.

Hanifin JM, Cooper KD, Ho VC, et al. Guidelines of care for atopic dermatitis, developed in accordance with the American Academy of Dermatology (AAD)/American Academy of Dermatology Association "Administrative Regulations for Evidence-Based Clinical Practice Guidelines". J Am Acad Dermatol. 2004;50(3):391-404.

Hayes, Inc. Health Technology Brief. Excimer Laser Therapy (ELT) for Vitiligo. November 2008.

Hayes, Inc. Custom Report. Phototherapy for Atopic Dermatitis. 2005 Hayes, Inc. Directory. Laser and Light Therapies for Rosacea. October 2007. Update search September 2008.

Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline Hayes, Inc. Directory. Laser Therapy for Psoriasis. 2003. Update Search March 2008. ARCHIVED November 2008.

Hayes Inc. Hayes Directory. Phototherapy for Acne Vulgaris. February 2009.

Hayes, Inc. Hayes Directory. Photodynamic Therapy for Actinic Keratoses. May 2004 Update Search October 2008.

Hayes, Inc. Hayes Directory. Pulsed Dye Laser for Cutaneous Vascular Lesions. January 2006. Update search January 2009.

Hayes, Inc. Search and Summary. Laser Therapy for Hidradenitis. October 2007. ARCHIVED. November 2008.

Hayes, Inc. Search and Summary. Ultraviolet Light B (UVB) Therapy for the Treatment of Guttate Psoriasis. August 2008.

Haedersdal, M, Togsverd-Bo, K, and Wulf, HC. Evidence-based review of lasers, light sources and photodynamic therapy in the treatment of acne vulgaris. J Eur Acad Dermatol Venereol. 2008;22(3):267-278.

Hohenleutner S, Badur-Ganter E, Landthaler M, Hohenleutner U. Long-term results in the treatment of childhood hemangioma with the flashlamp-pumped pulsed dye laser: an evaluation of 617 cases. Lasers Surg Med. 2001;28(3):273Hohenleutner S, Landthaler M. Laser treatment of childhood haemangioma: progress or not? Lancet. 2002;360(9332):502Hong SB, Park HH, Lee MH. Short-term effects of 308-nm xenon-chloride excimer laser and narrow-band ultraviolet B in the treatment of vitiligo: a comparative study. J Korean Med Sci. 2005 Apr;20(2):273-8.

Hongcharu W, Taylor CR, Chang Y, et al. Topical ALA-photodynamic therapy for the treatment of acne vulgaris. J Invest Dermatol. 2000;115(2):183-192.

Horfelt C, Funk J, Frohm-Nilsson M, et al. Topical methyl aminolaevulinate photodynamic therapy for treatment of facial acne vulgaris: results of a randomized, controlled study. Br J Dermatol. 2006 Sep;155(3):608-13.

Jih MH, Friedman PM, Goldberg LH, et al. The 1450-nm diode laser for facial inflammatory acne vulgaris: dose-response and 12-month follow-up study. J Am Acad Dermatol. 2006 Jul;55(1):80-7.

Jury CS, McHenry P, Burden AD, Lever R, Bilsland D. Narrowband ultraviolet B (UVB) phototherapy in children. Clin Exp Dermatol. 2006 Mar;31(2):196-9.

Kirke SM, Lowder S, Lloyd JJ, et al. A randomized comparison of selective broadband UVB and narrowband UVB in the treatment of psoriasis. J Invest Dermatol. 2007 Jul;127(7):1641-6.

Lapins J, Sartorius K, Emtestam L. Scanner-assisted carbon dioxide laser surgery: a retrospective follow-up study of patients with hidradenitis suppurativa. J Am Acad Dermatol. 2002 Aug;47(2):280-5.

Lonne-Rahm S, Nordlind K, Edstrom DW, et al. Laser treatment of rosacea: a pathoetiological study. Arch Dermatol.

2004;140(11):1345-1349.

Lu-yan T, Wen-wen F, Lei-hong X, Yi J, Zhi-zhong Z. Topical tacalcitol and 308-nm monochromatic excimer light: a synergistic combination for the treatment of vitiligo. Photodermatol Photoimmunol Photomed. 2006 Dec;22(6):310-4.

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, Lebwohl M, Koo JY, Elmets CA, Korman Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline NJ, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826Morton C, Campbell S, Gupta G, et al. Intraindividual, right-left comparison of topical methyl aminolaevulinatephotodynamic therapy and cryotherapy in subjects with actinic keratoses: a multicentre, randomized controlled study. Br J Dermatol. 2006 Nov;155(5):1029-36.

National Institute for Health and Clinical Excellence. Web site. Guidance for photodynamic therapy for non-melanoma skin

tumours (including premalignant and primary non-metastatic skin lesions). February 2006. Available at:

http://guidance.nice.org.uk/IPG155/guidance/pdf/English. Accessed February 2009.

Orringer JS, Kang S, Hamilton T, et al. Treatment of acne vulgaris with a pulsed dye laser: a randomized controlled trial.

JAMA. 2004;291(23):2834-2839.

Orringer JS, Kang S, Maier L, et al. A randomized, controlled, split-face clinical trial of 1320-nm Nd:YAG laser therapy in the treatment of acne vulgaris. J Am Acad Dermatol. 2007 Mar;56(3):432-8.

Ostovari N, Passeron T, Zakaria W, et al. Treatment of vitiligo by 308-nm excimer laser: an evaluation of variables affecting treatment response. Lasers Surg Med. 2004;35(2):152-6.

Pahlajani N, Katz BJ, Lozano AM, Murphy F, Gottlieb A. Comparison of the efficacy and safety of the 308 nm excimer laser for the treatment of localized psoriasis in adults and in children: a pilot study. Pediatr Dermatol. 2005 MarApr;22(2):161-5.

Papageorgiou P, Katsambas A, Chu A. Phototherapy with blue (415 nm) and red (660 nm) light in the treatment of acne vulgaris. Br J Dermatol. 2000;142(5):973-978.

Pariser D, Loss R, Jarratt M, et al. Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2008 Oct;59(4):569-76.

Piacquadio DJ, Chen DM, Farber HF, et al. Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp. Arch Dermatol. 2004;140(1):41-46.

Procaccini EM. Riccio G. Monfrecola G. Ineffectiveness of topical khellin in photochemotherapy of vitiligo. J Dermatol Treatment. 1995;6(2):117-120.

Raulin C, Greve B. Retrospective clinical comparison of hemangioma treatment by flashlamp-pumped (585 nm) and frequency-doubled Nd:YAG (532 nm) lasers. Lasers Surg Med. 2001;28(1):40-43.

Reynolds NJ, Franklin V, Gray JC, et al. Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial. Lancet. 2001;357(9273):2012-2016.

Sami, NA, Attia, AT, and Badawi, AM. Phototherapy in the treatment of acne vulgaris. J Drugs Dermatol. 2008;7(7):627Schiener R, Brockow T, Franke A,et al. Bath PUVA and saltwater baths followed by UV-B phototherapy as treatments for psoriasis: a randomized controlled trial. Arch Dermatol. 2007 May;143(5):586-96.

Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline Schroeter CA, Haaf-von Below S, Neumann HA. Effective treatment of rosacea using intense pulsed light systems. Dermatol Surg. 2005;31(10):1285-1289.

Shen Z, Gao TW, Chen L, et al. Optimal frequency of treatment with the 308-nm excimer laser for vitiligo on the face and neck. Photomed Laser Surg. 2007;25(5):418-427.

Sommer S, Sheehan-Dare RA. Pulsed dye laser treatment of port-wine stains in pigmented skin. J Am Acad Dermatol.

2000;42(4):667-671.

Spencer JM, Nossa R, Ajmeri J. Treatment of vitiligo with the 308-nm excimer laser: a pilot study. J Am Acad Dermatol.

2002;46(5):727-731.

Stern RS, Liebman EJ, Vakeva L. Oral psoralen and ultraviolet-A light (PUVA) treatment of psoriasis and persistent risk of nonmelanoma skin cancer. PUVA Follow-up Study. J Natl Cancer Inst. 1998;90(17):1278-1284.

Stern RS, Nichols KT, Vakeva LH. Malignant melanoma in patients treated for psoriasis with methoxsalen (psoralen) and ultraviolet A radiation (PUVA). The PUVA Follow-Up Study. N Engl J Med. 1997;336(15):1041-1045.

Stier MF, Glick SA, Hirsch RJ. Laser treatment of pediatric vascular lesions: Port wine stains and hemangiomas. J Am Acad Dermatol. 2008 Feb;58(2):261-85.

Strauss JS, Krowchuk DP, Leyden JJ, et al.; American Academy of Dermatology/American Academy of Dermatology Association. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007;56(4):651-663.

Tan ST, Bialostocki A, Armstrong JR. Pulsed dye laser therapy for rosacea. The Br J Plast Surg. 2004;57(4):303-310.

Taub AF. Treatment of rosacea with intense pulsed light. J Drugs Dermatol. 2003;2(3):254-259.

Tremblay JF, Sire DJ, Lowe NJ, Moy RL. Light-emitting diode 415 nm in the treatment of inflammatory acne: an openlabel, multicentric, pilot investigation. J Cosmet Laser Ther. 2006 Apr;8(1):31-3.

Uebelhoer NS, Bogle MA, Stewart B, Arndt KA, Dover JS. A split-face comparison study of pulsed 532-nm KTP laser and 595-nm pulsed dye laser in the treatment of facial telangiectasias and diffuse telangiectatic facial erythema. Dermatol Surg.

2007 Apr;33(4):441-8.

Weischer M, Blum A, Eberhard F, et al. No evidence for increased skin cancer risk in psoriasis patients treated with broadband or narrowband UVB phototherapy: a first retrospective study. Acta Derm Venereol. 2004;84(5):370-374.

Westerhof W, Nieuweboer-Krobotova L, Mulder PG, Glazenburg EJ. Left-right comparison study of the combination of fluticasone propionate and UV-A vs. either fluticasone propionate or UV-A alone for the long-term treatment of vitiligo.

Arch Dermatol. 1999;135(9):1061-1066.

Wiegell SR, Wulf HC. Photodynamic therapy of acne vulgaris using methyl aminolaevulinate: a blinded, randomized, controlled trial. Br J Dermatol. 2006a May;154(5):969-76.

Wiegell SR, Wulf HC. Photodynamic therapy of acne vulgaris using 5-aminolevulinic acid versus methyl aminolevulinate. J Am Acad Dermatol. 2006b Apr;54(4):647-51.

Yones SS, Palmer RA, Garibaldinos TM, Hawk JL. Randomized double-blind trial of treatment of vitiligo: efficacy of psoralen-UV-A therapy vs Narrowband-UV-B therapy. Arch Dermatol. 2007 May;143(5):578-84. Erratum in: Arch Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline Dermatol. 2007 Jul;143(7):906.

Yones SS, Palmer RA, Garibaldinos TT, Hawk JL. Randomized double-blind trial of the treatment of chronic plaque psoriasis: efficacy of psoralen-UV-A therapy vs narrowband UV-B therapy. Arch Dermatol. 2006 Jul;142(7):836-42.

History/Updates Policy revision with changes to coverage rationale. Updated CMS information. Deleted the following procedure 5/15/2009 codes from the coding section: 17110, 17111, 97028, E0202, E0691, E0692, E0693, E0694, J7308, and S8948.

Separated procedure codes into categories based on diagnoses. Policy 2008T0337D archived.

12/15/2008 Added diagnosis code 709.01 to the list of proven ICD 9 diagnosis codes.

10/30/2008 Policy revision with changes to coverage rationale. Policy named Light and Laser Therapy for Skin Conditions (2008T0337D). Policy combines 7 former policies: Atopic Dermatitis (Eczema), Phototherapy (2005T0135C), Photodynamic Therapy for Actinic Keratoses (2004T0337C), Phototherapy and Laser Treatment for Psoriasis (2005T0344E), Phototherapy, Light and Laser Treatment for Rosacea (2006T0491A), Phototherapy Treatment for Acne Vulgaris (2005T0487A), Phototherapy for Treatment of Vitiligo (2005T0327C), and Pulsed Dye Laser Therapy for Cutaneous Vascular Lesions (2005T0364C) which have been archived. The CMS information has been updated. CPT/HCPCS coding section has been updated and ICD 9 diagnosis and procedure codes have been added.

Medicare entry - no change in coverage - CIM 35-101.

6/7/2004 CPT code 96900 and ICD 9 codes 702.0 and 702.8 added to Coding Section per direction from the 2/24/2004 Reimbursement Medical Policy Operations Manager.

Yearly update. Revisions/additions in multiple sections with change in coverage rationale.

2/19/2004 Policy Reformatted 2/28/2002 Contact Information For questions regarding this policy, send an email to the Medical Technology Interpretation Service at medical_drug_interpretation@uhc.com with the word "Medical" in the subject line.

Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.

Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.

Acne Vulgaris Procedure Codes 17000 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); first lesion 17003 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); second through 14 lesions, each (List separately in addition to code for first lesion) 17004 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline lesions (eg, actinic keratoses), 15 or more lesions 96567 Photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa (eg, lip) by activation of photosensitive drug(s), each phototherapy exposure session 96900 Actinotherapy (ultraviolet light) 96912 Photochemotherapy; psoralens and ultraviolet A (PUVA) 96913 Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision of the physician (includes application of medication and dressings) Acne Vulgaris Diagnosis Codes

704.09 Other alopecia

704.8 Other specified disease of hair and hair follicles

706.0 Acne varioliformis

706.1 Other acne Actinic Keratosis Pocedure Codes 17000 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); first lesion 17003 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); second through 14 lesions, each (List separately in addition to code for first lesion) 17004 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses), 15 or more lesions 96567 Photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa (eg, lip) by activation of photosensitive drug(s), each phototherapy exposure session Actinic Keratosis Diagnosis Codes

702.0 Actinic keratosis Atopic Dermatitis Procedure Codes 96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B 96912 Photochemotherapy; psoralens and ultraviolet A (PUVA) 96913 Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision of the physician (includes application of medication and dressings) 96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm 96921 Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm 96922 Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm Atopic Dermatitis Diagnosis Codes

686.8 Other specified local infections of skin and subcutaneous tissue Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline

691.8 Other atopic dermatitis and related conditions

692.0 Contact dermatitis and other eczema due to detergents Cutaneous Vascular Lesion Procedure Codes 17106 Destruction of cutaneous vascular proliferative lesions (eg, laser technique); less than 10 sq cm 17107 Destruction of cutaneous vascular proliferative lesions (eg, laser technique); 10.0 to 50.0 sq cm 17108 Destruction of cutaneous vascular proliferative lesions (eg, laser technique); over 50.0 sq cm Cutaneous Vascular Diagnosis Codes

228.00 Hemangioma of unspecified site

228.01 Hemangioma of skin and subcutaneous tissue

448.0 Hereditary hemorrhagic telangiectasia

448.1 Nevus, non-neoplastic

757.32 Congenital vascular hamartomas

759.6 Other congenital hamartoses, not elsewhere classified Hydradenitis Procedure Codes 96567 Photodynamic therapy by external application of light to destroy premalignant and/or malignant lesions of the skin and adjacent mucosa (eg, lip) by activation of photosensitive drug(s), each phototherapy exposure session 96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm 96921 Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm 96922 Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm Hydradenitis Diagnosis Code

705.83 Hidradenitis Psoriasis Procedure Codes 96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B 96912 Photochemotherapy; psoralens and ultraviolet A (PUVA) 96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm 96921 Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm 96922 Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm Psoriasis Diagnosis Codes

696.0 Psoriatic arthropathy

696.1 Other psoriasis and similar disorders Rosacea Procedure Codes Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline 96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B 96912 Photochemotherapy; psoralens and ultraviolet A (PUVA) 96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm 96921 Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm 96922 Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm Rosacea Diagnosis Code

695.3 Rosacea Vitiligo Procedure Codes 96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B 96912 Photochemotherapy; psoralens and ultraviolet A (PUVA) 96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm 96921 Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm 96922 Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm Vitiligo Diagnosis Codes

709.00 Dyschromia, unspecified

709.01 Vitiligo This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Light and Laser Therapy for Skin Conditions - Commercial Medical Management Guideline TITLE: Lithotripsy for Salivary Stones Authorized By: Medical Management Guideline Committee

Adoption Date: 09/16/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

A This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Lithotripsy for Salivary Stones - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Extracorporeal shock wave lithotripsy (ESWL) is unproven for the treatment of salivary stones. While the results of studies for ESWL are promising, there is a need for further medical research with randomized controlled studies to demonstrate the effectiveness of ESWL.

Endoscopic intracorporeal laser lithotripsy is unproven for the treatment of salivary stones.The evidence regarding intracorporeal laser lithotripsy is limited, based on fewer studies involving smaller numbers of patients and results are less consistent. There is insufficient data at this time to evaluate the efficacy of laser lithotripsy.

Regulatory Requirements U.S. Food and Drug Administration (FDA): The FDA has not approved the use of lithotripters for the treatment of salivary stones. See the following website for information regarding FDA approved micro or miniature endoscopes for Ear, Nose and Throat (ENT) applications. Use product codes EOB and EOQ.

Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 2009.

Research Evidence Background Salivary glands, located near the mouth and throat, secrete saliva into the mouth aiding in digestion, moistening the mouth and protecting teeth from decay. The major salivary glands include the submandibular, sublingual and parotid glands. In addition to these glands, there are many minor salivary glands located throughout the mouth and throat.

Sialolithiasis, the formation of salivary stones due to crystallization of minerals in saliva, can cause blockage of salivary ducts resulting in painful inflammation, especially during or after meals. Most salivary stones occur in the submandibular gland, followed by the parotid gland and infrequently in the sublingual or minor salivary glands. While smaller stones may pass on their own, larger stones generally require medical or surgical intervention. Surgery, however, carries risks, such as possible injury to the facial nerves. Therefore, minimally invasive and nonsurgical techniques of treating salivary stones have been evolving rapidly.

Extracorporeal shock wave lithotripsy (ESWL) is one minimally invasive approach that uses high energy shock waves generated outside the body to pulverize or crush the stones inside the body. Iro and colleagues in Germany, were the first to report the use of ESWL to disintegrate the salivary stone into smaller pieces to permit spontaneous or induced salivation to flush out the sandy material. (Iro, 1990) Intracorporeal laser lithotripsy, with the guide of a flexible endoscope, is also used to treat salivary stones. In this procedure, a pulsed dye laser is used to fragment the salivary stones inside the body. Higher energy levels may be used without causing adjacent tissue injury since delivery is pulsed, or intermittent, reducing the risk of excessive thermal build-up that is possible with a continuous laser.

Research Evidence In a retrospective analysis, Schmitz, et al. observed 167 patients over 7 years. Successful treatment with total stone disintegration was achieved in 51 (31 per cent) patients. In 92 (55 per cent) patients, treatment was partially successful, with disappearance of the symptoms but a sonographically still identifiable stone. Treatment failure occurred in 24 (14 per cent) patients who then underwent surgery. The mean follow-up period was 35.6 months (minimum three, maximum 83), after which 83.2 per cent of the initially successfully treated patients were still free of symptoms. (Schmitz, 2008)

Lithotripsy for Salivary Stones - Commercial Medical Management Guideline

Raif, et al. tested an Er:YAG fiber delivery system for endoscopic lithotripsy of salivary stones in 17 patients. Of the 21 stones treated clinically, 5 were fully fragmented, 7 were prepared for extraction by mini forceps and 9 were released from surrounding soft tissues for subsequent removal. Fifteen of the 18 treated glands returned to normal function without any symptoms. (Raif, 2006) In a review of minimally invasive approaches to salivary gland obstruction, Brown reported that ESWL has been shown to totally break and eliminate stones in 39 to 65% of patients, with the greatest success being observed in parotid stones and in stones smaller than 7 mm in diameter. He further reported that 26 to 34% of patients were made symptom-free even where some stone fragments remained, thus achieving an asymptomatic state in 76 to 84% of patients. Stone fragments should be expelled with normal salivary flow, but a functioning gland and patent duct are required for this to occur. He went on to report that studies of intracorporeal lithotripsy have been small and success rates variable, with reports of damage to the duct wall. (Brown, 2006) McGurk et al. studied 455 salivary calculi that were treated by ESWL, fluoroscopically guided basket retrieval or intraoral stone removal. The techniques were used alone or in combination. ESWL resulted in complete success in 87 (39.4%) of 221 patients (84 of 218 primary and all of 3 secondary procedures; 43 of 131 submandibular and 44 of 90 parotid). (McGurk, 2005) Capaccio et al. conducted a consecutive patient series that assessed 322 patients with salivary calculi who underwent electromagnetic ESWL. Complete elimination of the stone was accomplished in 45% of patients. Residual fragments (less than 2 mm in diameter) were detected by ultrasound in 27.3% of patients, and persisting fragments greater than 2 mm in diameter were found in 27.7% of patients. Recurrence of calculi was observed during a median follow-up of 57 months in 4 patients with complete ultrasonographic clearance of the stone occurring 10 to 58 months after lithotripsy. A favorable treatment result was associated with younger age, parotid site of the stone, stone diameter less than or equal to 7 mm, and 6 or fewer therapeutic session. (Capaccio, 2004) Zenk et al. studied 197 patients with submandibular stones who were treated with ESWL from 1989 to 1994. The review analysis was completed in 2002. Thirty-five percent of the patients were either free of stones or had no symptoms from residual stones. Another 15% had a significant symptom improvement and needed no further therapy. The remaining 50% of patients had residual stones and no symptoms in the short review period, but have had symptoms since.

Therapeutic success was influenced by stone location in the gland rather than stone size. (Zenk, 2004) In a review of treatment options for submandibular salivary stones, Baurmash remarked that lithotripsy does not appear to be a viable routine method of management. (Baurmash, 2004) Marchal reviewed various therapeutic approaches to salivary stones and reported that with ESWL, once fragmented, stones are expected to evacuate spontaneously since no stone extraction is described with this technique. The remaining stone debris may lead to further calcification and stone recurrence. Success rates up to 75% for the parotid and up to 40% for the submandibular gland have been reported and are similar for external and intracannular lithotripsy. (Marchal, 2003) In a study of 122 salivary calculi treated by ESWL, Escudier reported complete success in 33% of patients. Thirty-five percent of patients were asymptomatic, although some stone debris remained in the duct. Failure occurred in 32% of the patients. The chance of failure increased with the size of the calculus and increasing symptom duration. (Escudier, 2003) While the results of studies evaluating lithotripsy for treating salivary stones are promising, there is a need for additional research. Studies have thus far been small to moderate in size and uncontrolled.

Additional Search Terms Lithotripsy for Salivary Stones - Commercial Medical Management Guideline parotid calculi, submandibular calculi, sialadenitis, sialoendoscopy References and Resources Resources Baurmash HD. Submandibular salivary stones: current management modalities. J Oral Maxillofac Surg. 2004 Mar;62(3):369-78.

Brown JE. Interventional sialography and minimally invasive techniques in benign salivary gland obstruction. Semin Ultrasound CT MR. 2006 Dec;27(6):465-75.

Capaccio P, Ottaviani F, Manzo R, Schindler A, Cesana B. Extracorporeal lithotripsy for salivary calculi: a long-term clinical experience. Laryngoscope. 2004 Jun;114(6):1069-73.

Escudier MP, Brown JE, Drage NA, McGurk M. Extracorporeal shockwave lithotripsy in the management of salivary calculi. Br J Surg. 2003 Apr;90(4):482-5.

Hayes, Inc. Hayes Directory. Lithotripsy for Salivary Stones. Lansdale, PA: Hayes, Inc.; January 2000. Archived January 2007.

Iro H, et al. Extracorporeal piezoelectric lithotripsy of salivary calculi. Initial clinical experiences [Article in German].

HNO. 1990 Jul;38(7):251-5.

Marchal F, Dulguerov P. Sialolithiasis management: the state of the art. Arch Otolaryngol Head Neck Surg. 2003 Sep;129(9):951-6.

McGurk M, Escudier MP, Brown JE. Modern management of salivary calculi. Br J Surg. 2005 Jan;92(1):107-12.

Raif J, Vardi M, Nahlieli O, Gannot I. An Er:YAG laser endoscopic fiber delivery system for lithotripsy of salivary stones. Lasers Surg Med. 2006 Jul;38(6):580-7.

Schmitz S, Zengel P, Alvir I, et al. Long-term evaluation of extracorporeal shock wave lithotripsy in the treatment of salivary stones. J Laryngol Otol. 2008 Jan;122(1):65-71.

Zenk J, Bozzato A, Winter M, Gottwald F, Iro H. Extracorporeal shock wave lithotripsy of submandibular stones:

evaluation after 10 years. Ann Otol Rhinol Laryngol. 2004 May;113(5):378-83.

–  –  –

Lithotripsy for Salivary Stones - Commercial Medical Management Guideline Policy Reformatted including Coverage and Clinical Recommendations sections 2/19/2002 Contact Information For questions regarding this policy, send an email to the Medical Technology Interpretation Service at medical_drug_interpretation@uhc.com with the word "Medical" in the subject line.

Coding The Current Procedural Terminology (CPT) codes and HCPCS codes listed in this policy are for reference purposes only.

Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the benefit document.

–  –  –

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Lithotripsy for Salivary Stones - Commercial Medical Management Guideline

–  –  –

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services



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