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MP 2.01.69 Laser Treatment of Active Acne ARCHIVED

Medical Policy
Section
Medicine
 
Original Policy Date
11/9/04
Last Review Status/Date
Archived/12:2009
Issue
12:2009
Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

Lasers have been used to treat acne scarring, and may also be useful for active acne. Various types of laser treatments are available, including pulsed and non-pulsed devices, and differing wavelengths of emitted light. Lasers may improve active acne by killing propionibacterium acnes (P. acnes) and/or by reducing inflammation.

Acne is a very 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 with the greatest concentration of sebaceous glands, i.e., the face, neck, and upper part of the trunk. The 4 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 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 affects (i.e., red light of 660 nm) that 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.

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 1320 nm (Candela Smoothbeam™ and CoolTouch®), intense pulsed light systems, which emit light in the range of 590 to 1200 nm (Radiancy ClearTouch™,MED flash IIand EllispseI 2 PL), 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. A thermal device (ThermaClear™) received 510(k) approval in 2006 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.

 

Note: Photodynamic therapy as a treatment of acne is addresses in policy No. 2.01.44.


Policy

Laser treatment of active acne is considered investigational. (See Benefit Application section regarding exclusions for cosmetic services.)


Policy Guidelines

CPT codes 17110-17111 [destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular lesions] are not specific to acne lesions but would be used for this procedure if it is performed to destroy milia. For other laser treatment of acne, CPT code 17999 would be the more appropriate code. 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).

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


Benefit Application

BlueCard/National Account Issues

Some state or federal mandates (e.g., Federal Employee Program [FEP]) prohibit Plans from denying FDA-approved technologies 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. Please refer to policy No. 10.01.09 for further discussion on cosmetic/reconstructive services.


Rationale

An initial literature search of MEDLINE through September 2004 was conducted when the policy was created. Since that time, the policy has been updated regularly with a literature review using MEDLINE; most recently, the literature search was conducted from April 2008 through September 2009.

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 (2.01.44). 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 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 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 below:

  • Seaton et al., 2003: This was double-blind RCT of 41 adults with mild to moderate facial inflammatory acne (i.e., a Leeds acne severity score of between 2 and 7). 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% and 9% and inflammatory lesion counts fell by 49% and 10% 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 2 or greater) randomized to receive either 1 or 2 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 1320-nm laser (CoolTouch II) in 46 patients in a split-face design. Laser treatment was given once every 3 weeks, with blinded evaluation by a panel of 3 dermatologists (from photographs taken at 7 and 14 weeks). Thirty patients completed the 14-week assessment (35% 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 7-week assessment; not blinded to treatment) favored the treated side over the control side for a decrease in acne (59%) and oily skin (54%). No differences were found between the treated and un-treated 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. They were randomly assigned to 1 of 3 groups (15 patients per group). Group A received pulsed dye laser therapy (3 J/cm2 fluence) every 2 weeks for 6 sessions; Group B applied topical treatment with 0.1% tretinoin cream every evening and 5% benzoyl peroxide gel every morning; and Group C underwent chemical peeling using trichloroacetic acid 25%. 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 3 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 between the three groups. The proportion of patients with moderate side effects was 23% in Group A, 15% in Group B and 13% 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 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 on-line 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)

Medicare National Coverage

No national coverage determination.

 

References:

  1. Hamilton FL, Car J, Lyons C et al. Laser and other light therapies for the treatment of acne vulgaris: systematic review. Br J Dermatol 2009; 160: 1273-1285.
  2. Haedersdal M, Togsverd-Bo K, Wiegell SR et al. Long-pulsed dye laser versus long-pulsed dye laser-assisted photodynamic therapy for acne vulgaris: a randomized controlled trial. J Am Acad Dermatol 2008; 58(3):387-94.
  3. 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.
  4. 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.
  5. 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):432-8.
  6. Laheta TM. Role of the 585-nm pulsed dye laser in the treatment of acne in comparison with other topical therapeutic modalities. J Cesmetic Laser Ther 2009; 11: 118-124.
  7. http://www.skincarephysicians.com/acnenet/PhysicalProcedures.html. Last accessed October 2009.

 

 

Codes

Number

Description

CPT  17110–17111  Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular lesions   
17999 Unlisted procedure, skin, mucous membrane and subcutaneous tissue 
ICD-9 Procedure  86.3  Other local excision or destruction of lesion or tissue of skin and subcutaneous tissue; destruction of skin by cauterization, cryosurgery, fulguration or laser beam 
ICD-9 Diagnosis  706.1  Acne: NOS, vulgaris, conglobata, cystic, pustular blackhead, comedo 
HCPCS     


Index

Acne, Laser Treatment
Laser Treatment, Acne


Policy History

Date Action Reason
11/9/04 Add to Medicine section New policy; literature review through September 2004
12/15/05 Replace policy Policy updated with literature search; policy statement unchanged.
04/17/07 Replace policy Policy updated with literature search; reference numbers 5-7added; devices (FDA cleared) added; policy statement unchanged
06/12/08 Replace policy  Policy updated with literature search; reference 8 added; policy statement unchanged
12/03/09 Policy archived  


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