Description
Acne is a common disorder of the pilosebaceous follicles that primarily affects adolescents and young adults and may be classified as inflammatory or noninflammatory. Acne is characterized by comedones, nodules and eruptions of papules, pustules and nodulocystic lesions. Lesions are found in areas where there is the greatest concentration of sebaceous glands, i.e., the face, neck and upper part of the trunk. The four causal factors of acne are androgen-mediated sebaceous gland hyperplasia and excess sebum production; abnormal follicular keratinization, which results in plugging of the follicles and comedo formation; proliferation of propionibacterium acnes (P acnes); and inflammation resulting from the chemoattractant and proinflammatory byproducts of P acnes. Genetic factors, diet and stress may also contribute to the development and severity of acne. Treatment of active acne usually consists of a good skin care regimen, benzoyl peroxide, antibiotics and retinoids. Active acne is distinct from acne scarring, which may occur from tissue damage after inflammatory lesions subside.

Pulsed dye laser has been used in the treatment of acne scarring; however, more recently, lasers have been investigated for the treatment of active inflammatory acne. Laser therapy at various irradiation levels or fluences (e.g., low- and mid-level irradiation lasers and long pulse diode lasers) has been used to destroy active acne lesions and enlarged sebaceous glands. Lasers are believed to improve active acne lesions by reducing the presence of P acnes, which contain porphyrins that are destroyed by exposure to light of specific wavelengths (i.e., blue light of 405-420 nm). Lasers may also have anti-inflammatory effects (i.e., red light of 660 nm), which may improve active acne. Low fluence pulsed dye lasers are less ablative and purpuric and may be preferred in active acne treatment to limit tissue damage and potential treatment-related scarring. Laser treatment of active acne lesions may also reduce potential acne scarring that can occur in severe cases.

Note: This policy does not apply to the treatment of acne scarring.

Regulatory Status 
A number of laser and focused light devices have received marketing clearance for the treatment of acne via the U.S. Food and Drug Administration’s (FDA’s) 510(k) mechanism. These include lasers that emit light at 1,320 nm (Candela Smoothbeam^™ and CoolTouch^®); intense pulsed light systems, which emit light in the range of 590 to 1,200 nm (Radiancy ClearTouch^™, MED flash II and Ellispse I2PL); pulsed dye lasers (ICN Photonics NLite System); and lasers or high-intensity light devices, which emit violet or blue (around 414 nm) and red (around 633 nm) light (Aura^™, Clearlight and Dermillume). The specific indications for these devices vary; Candela Smoothbeam^™ is indicated solely for the treatment of acne on the back; others are indicated for the treatment of inflammatory acne or for mild to moderate acne with no location specified. In 2006, a thermal device (ThermaClear^™) was cleared for marketing for the "treatment of individual acne pimples in persons with mild to moderate inflammatory acne" in both a practitioner’s office environment and a consumer home-use environment.

Related Policies
20144  Dermatologic Applications of Photodynamic Therapy

Policy
Laser treatment (e.g., the Candela Smooth Beam Laser System) of active acne is considered INVESTIGATIONAL  because the effectiveness for this treatment has not been established. (See Benefit Application section regarding exclusions for cosmetic services.)

Policy Guidelines
CPT codes 17000-04 [destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), all benign or premalignant lesions (e.g., actinic keratoses) other than skin tags or cutaneous vascular proliferative lesions] are not specific to acne lesions. To identify laser treatments for acne, the CPT code can be coupled with the ICD-9 code of 706.1 (Acne: NOS, vulgaris, conglobata, cystic, pustular, blackhead, comedo).

Published research on laser treatment for active acne has focused on no more than one or two laser treatment sessions. However, Plans may wish to monitor for multiple laser treatments for the same patient.

Benefit Application
BlueCard/National Account Issues
Some state or federal mandates (e.g., FEP) prohibit Plans from denying technologies approved by the U.S. Food and Drug Administration (FDA) as investigational. In these instances, Plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone.

Plans may wish to examine specific contract language regarding the definitions of cosmetic services to determine whether contract or benefit exclusions may apply to the treatment of active acne.

Rationale
Two systematic reviews of light therapies for treatment of active acne were identified. Both reviews included studies on photodynamic therapy, as well as light and laser therapy. Trials on photodynamic therapy (PDT) will not be discussed further, as they are addressed in another policy (20144). Neither review conducted any pooled analyses of laser treatment studies due to heterogeneity between studies (e.g., different wavelengths of light were used). The two systematic reviews had similar assessments of the literature. Hamilton and colleagues identified 10 randomized controlled trials comparing light therapy to placebo and three RCTs comparing light therapy to topical treatment of acne.¹ The authors commented that studies of light therapy tended to be small (all had fewer than 50 participants), of short duration and of variable quality and that a few compared light therapy to conventional treatment. They concluded: "Our review found only limited or no benefit is given by light therapies alone. ... Further trials comparing light therapy with usual treatment, using a larger effect size in the power calculations, would be helpful to determine the usefulness of light therapy in treating acne." The other systematic review by Haedersdal and colleagues included 11 RCTs on light treatments (other than photodynamic therapy) and stated that most of the studies had suboptimal methods.² For example, few studies described their randomization method and most had large losses to follow-up without intention-to-treat analysis. The authors state, "Based on the present best available evidence, we conclude that optical treatments with lasers, light sources and PDT possess the potential to improve inflammatory acne on a short-term basis with the most consistent outcomes for PDT. We recommend that patients are informed of the existing evidence, which denotes that optical treatments for acne today are not included among first-line treatments." There is no separate conclusion focusing on laser therapy. The systematic reviews identified a number of side effects from optical treatments, and these include pain, erythema, edema, crusting, hyperpigmentation and pustular eruptions.

Key individual RCTs with at least 40 participants are described as follows:

• Seaton et al., 2003: This trial was a double-blind RCT of 41 adults with mild to moderate facial inflammatory acne (i.e., Leeds acne severity score of between two and seven). Patients were randomized to receive a single low fluence pulsed dye laser treatment or sham treatment. At 12 weeks, Leeds acne scores fell from 3.8 to 1.9 in the treatment group and from 3.6 to 3.5 in the control group. Total lesion counts fell by 53 percent and 9 percent and inflammatory lesion counts fell by 49 percent and 10 percent in the laser treatment group and control group, respectively. While the authors reported statistically significant improvements, they concluded that "laser treatment should be further explored as an adjuvant or alternative to daily conventional pharmacological treatments."³
• Orringer et al., 2004: The article reported on a single-blind, split-face RCT of 40 patients (aged 13 years or older with a Leeds acne score of two or greater) who were randomized to receive either one or two sessions of pulsed dye laser treatment (3 J/cm2 fluence) to half of the face with the opposite, non-treated side serving as the control. At 12 weeks, changes in lesion counts (including pustules, comedones, macules, cysts and papules) and mean Leeds acne scores were not significantly different for the treated versus untreated sides of the face. The authors concluded that "additional well designed studies are needed before the use of pulse dye laser becomes a part of acne therapy."⁴
• Orringer et al., 2007: This RCT assessed the efficacy of a 1,320-nm laser (CoolTouch II) in 46 patients in a split-face design. Laser treatment was given once every three weeks, with blinded evaluation by a panel of three dermatologists (from photographs taken at seven and 14 weeks). Thirty patients completed the 14-week assessment (35 percent dropout); data were carried forward to adjust for subjects who may have dropped out of the study due to lack of effect. The authors report that the treated side remained unchanged at 0.22 cysts (10 total cysts in 46 subjects) while the untreated side increased from 0.27 to 0.70 cysts. Subjective patient reports (of 37 who completed at least the seven-week assessment; not blinded to treatment) favored the treated side over the control side for a decrease in acne (59 percent) and oily skin (54 percent). No differences were found between the treated and untreated sides in the number of papules, pustules, open comedones or closed comedones at 14 weeks.⁵
• Laheta, 2009: This study included 45 patients with mild to moderate acne who were randomly assigned to one of three groups (15 patients per group). Group A received pulsed dye laser therapy (3 J/cm2 fluence) every two weeks for six sessions; Group B applied topical treatment with 0.1 percent tretinoin cream every evening and 5 percent benzoyl peroxide gel every morning; and Group C underwent chemical peeling using trichloroacetic acid 25 percent. An assessor blinded to treatment group evaluated outcomes; 41 patients were included in the analysis. There was no significant difference between groups in the acne severity score (0 = no acne to 10 = severe acne) at the end of the three-month treatment period. Mean scores were 0.56 ± 0.57 for Group A, 0.65 ± 0.47 for Group B and 0.68 ± 0.50 for Group C (p = 0.38). The analysis of disease severity did not adjust for baseline scores, and standard deviations were large due to the small number of participants in each group. The degree of clinical response (marked or moderate) and side effects (trace, mild or moderate) also did not differ significantly among the three groups. The proportion of patients with moderate side effects was 23 percent in Group A, 15 percent in Group B and 13 percent in Group C (overall p-value = 0.95).⁶

Summary
Due to the small sample sizes of the published trials, lack of long-term follow-up, small number of studies on any particular type of laser and paucity of studies comparing light therapy to standard acne treatments, the evidence is insufficient to draw conclusions about the impact of laser treatments on health outcomes in patients with active acne. Therefore, the technology is considered investigational.

Technology Assessments, Guidelines and Position Statements
America Academy of Dermatology (AAD): An online information sheet endorsed by the AAD states: "Several laser and light treatments are available to treat acne. Some of these laser and light treatments target only one factor that causes acne. For many patients, this is not a comprehensive treatment for resolving their acne. A dermatologist can determine if laser or light treatment is appropriate for a patient. Advantages to laser and light treatments include not having to remember to apply or take any medication and the ability to treat hard-to-reach areas, such as the back. However, laser and light treatments can be quite expensive, and long-term effectiveness has not been proven."⁷

References:

1. Seaton ED, Charakida A, Mouser PE et al. Pulsed-dye laser treatment for inflammatory acne vulgaris: randomized controlled trial. Lancet 2003; 362(9393):1347-52.
2. 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):2834-9.
3. Harper JC. An update on the pathogenesis and management of acne vulgaris. J Am Acad Dermatol 2004; 51(1 suppl):S36-8.
4. Bhardwaj SS, Rohrer TE, Arndt K. Lasers and light therapy for acne vulgaris. Semin Cutan Med Surg. 2005;24(2):107-112.
5. Borelli C, Merk K, Plewig G, Degitz K. Light, laser and PDT therapy for acne. Hautarzt. 2005;56(11):1027-1032.
6. 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;55(1):80-87.
7. 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;56(3):432-438.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines

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