DESCRIPTION
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 II and Ellispse I2PL); 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, listing ClearTouch™ as a predicate device. Equivalence was based on the proposition that “ThermaClear™ and its predicate devices are all devices that use either heat or light to treat the dermatological condition of mild to moderate acne by exposing the surface of the skin to a precise energy fluence.”
Note: This policy does not address the treatment of acne scarring.
POLICY
Laser therapy for the treatment of acne is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of laser therapy for the treatment of acne compared to alternative treatments. The health outcomes have not been shown to be improved with this technology over the standard conventionally accepted therapy for acne.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2009). Laser treatment of acne (2.01.69). Retrieved June 29, 2010 from BlueWeb. (7 articles and/or guidelines reviewed)
Gold, M. (2007). Efficacy of lasers and PDT for the treatment of acne vulgaris. Skin Therapy Letter, 12 (10), 1 - 6. (Level 5 Evidence)
Haedersdal, M., Togsverd-Bo, K., & Wulf, H. (2008). Evidence-based review of lasers, light sources and photodynamic therapy in the treatment of acne vulgaris. Journal of European Academy and Venereology, 22 (3), 267 0- 278. (Level 5 Evidence)
Harto, A., Garcia-Morales, I., Belmar, P., & Jaen, P. (2007). Pulsed dye laser treatment of acne. Study of clinical efficacy and mechanism of action. Actas Dermo-sifiliograficas, (98 (6), 415 - 416. (Level 2 Evidence)
Hayes. Medical Technology Directory. (2009, February). Phototherapy for acne vulgaris. Retrieved June 29, 2010 from www.Hayesinc.com/subscribers. (57 articles and/or guidelines reviewed)
Ingram, J., Brindlay, D., & Williams, H. (2010). Management of acne vulgaris: an evidenced-based update. Clinical and Experimental Dermatology, 35 (4), 351 - 354. (Level 5 Evidence)
Karsai, S., Schmitt, L, & Raulin, C. (2010). The pulsed-dye laser as an adjuvant treatment modality in acne vulgaris: a randomized controlled single-blinded trial. British Journal of Dermatology, [Epub ahead of print]. (Level 1 Evidence)
Konishi, N., Endo, H., Oiso, N., Kawara, S., & Kawada, A. (2007). Acne phototherapy with a 1450-nm diode laser: an open study. Therapeutics and Clinical Risk Management, 3 (1), 205 - 209. (Level 4 Evidence)
National Guidelines Clearinghouse. Finnish Medical Society Duodecim. (2007, April). Acne. Retrieved June 29, 2010 from http://www.guidelines.gov.
National Guidelines Clearinghouse. Guideline Index. American Academy of Dermatology. (2007, April). Guidelines of care for acne vulgaris management. Retrieved June 29, 2010 from http://www.guidelines.gov.
Nestor, M. (2007). The use of photodynamic therapy for treatment of acne vulgaris. Dermatologic Clinics, 25 (1), 47 - 57. (Level 5 Evidence)
Nouri, K., & C. Ballard, C. (2006, January). Laser therapy for acne. Clinics in Dermatology, (24) Issue 1, 26-32.
Orringer, J., Kang, S., Maier, L., Johnson, T., Sachs, D., Karimipour, K., et al. (2007). A randomized, controlled, split-face clinical trial of 1320-nm Nd: YAG laser therapy in the treatment of acne vulgaris. Journal of American Academy of Dermatology, 56 (3), 432 - 438. (Level 1 Evidence)
Orringer, J., Sach, D., Bailey, E., Kang, S., Hamilton, T. & Voorhees, J. (2010). Photodynamic therapy for acne vulgaris: a randomized, controlled, split-face clinical trial of topical aminolevulinic acid and pulsed dye laser therapy. Journal of Cosmetic Dermatology, 9 (1), 28 - 34. (Level 1 Evidence)
Strauss, J., Krowchuk, D., Leyden, J., Lucky, A., Shalita, A., Siegfried, E., et al. (2007). Guidelines of care for acne vulgaris management. Journal of American academy of Dermatology, 56 (4), 651 - 663. (Level 5 Evidence)
U. S. Food and Drug Administration. (2006. October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060653. Retrieved June 29, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K060653.pdf.
U. S. Food and Drug Administration. (2010. April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K090744. Retrieved June 29, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090744.pdf.
ORIGINAL EFFECTIVE DATE: 5/12/2005
MOST RECENT REVIEW DATE: 8/12/2010
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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