DESCRIPTION
Blue light (i.e., ClearLight™) is a high intensity lamp intended for the treatment of acne vulgaris. It emits visible light in the violet-blue spectrum. It is thought that the violet-blue spectrum of high-intensity light triggers the proliferation of endogenic porphyrins, which attack and destroy the acne bacteria within the skin.
POLICY
Blue light for the treatment of acne vulgaris is considered investigational.
See also: Photodynamic Therapy (PDT) with Aminolevulinic Acid for the Treatment of Actinic Keratoses
ADDITIONAL INFORMATION
Available data is insufficient to evaluate the effectiveness or safety of this treatment for acne vulgaris.
Blue light for the treatment of acne vulgaris does not meet the following technology evaluation criteria:
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
American Academy of Dermatology Association. (2003). Guidelines of care for acne vulgaris. Retrieved September 30, 2003 from http://www.aadassociation.org/Guidelines/vulgaris.html.
American Academy of Dermatology Association. (2005). Guidelines of care for acne vulgaris management. Retrieved May 25, 2006 from http://www.aad.org/NR/rdonlyres/B91D1F7D-D178-4B7A-B1A2-D5DFD2F48DDC/0/guideline_acne.pdf.
American Academy of Dermatology Association. (2006). Acne. Retrieved May 25, 2006 from http://www.aadassociation.org/Guidelines/vulgaris.html.
Blue Light (ClearLight) for Acne Vulgaris. (2003, June). The Medical Letter On Drugs and Therapeutics, 45 (Issue 1159B), 50-51.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2005). Photodynamic Therapy for the Treatment of Actinic Keratoses and Other Skin Lesions (2.01.44). Retrieved May 25, 2006 from BlueWeb.
Elman, M., Slatkine, M., & Harth, Y. (2003). The effective treatment of acne vulgaris by a high-intensity, narrow band 405-420 nm light source. Journal of Cosmetic and Laser Therapy, 5 (2), 111-117. Abstract retrieved September 26, 2003 from PubMed database.
Institute for Clinical Systems Improvement. (2006, May). Health care guideline: Acne management. Retrieved May 25, 2006 from http://www.icsi.org/knowledge/detail.asp?catID=182&itemID=1997.
Kawada, A., Aragane, Y., Kameyama, H., Sangen, Y., & Tezuka, T. (2002). Acne phototherapy with a high-intensity, enhanced, narrow-band, blue light source: An open study and in vitro investigation. Journal of Dermatological Science, 30 (2), 129-135. Abstract retrieved September 26, 2006 from PubMed database.
Morton, C. A., Scholefield, R. D., Whitehurst, C., & Birch, J. (2005). An open study to determine the efficacy of blue light in the treatment of mild to moderate acne. Journal of Dermatological Treatment, 16 (4), 219-223. Abstract retrieved June 20, 2006 from PubMed database.
Shalita, A. R., Harth, Y., & Elman M. (2001). Acne PhotoClearing (APC™) using a novel, high-intensity,enhanced, narrow-band, blue light source. Clinical Application Notes, 9 (1), 1-4.
Tanzi, E. L., Lupton, J. R., & Alster, T. S. (2003). Lasers in dermatology: Four decades of progress. Journal of the American Academy of Dermatology, 49 (1), 1-59.
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K013623. Retrieved September 26, 2003 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=PMN&ID=K013623.
U. S. Food and Drug Administration. (2005, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K043575. Retrieved September 26, 2003 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=PMN&ID=K043575.
U. S. Food and Drug Administration. (2005, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051259. Retrieved September 26, 2003 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=PMN&ID=K051259.
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EFFECTIVE DATE |
8/10/2006 |
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