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FDA clears first acne treatment device

IsraelWednesday, August 21, 2002, 08:00 Hrs  [IST]

The U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to the first acne treatment device for moderate inflammatory acne vulgaris. Lumenis Ltd informed that the ClearLight system uses high-intensity, narrow-band phototherapeutic light to destroy the bacteria that cause acne. Acne, a disease involving the sebaceous glands of the skin, is estimated to affect more than 80% of the world's population at some time during their life. Not surprisingly, 30% of all dermatologist visits each year are for acne related causes and, in the U.S., more than $1.4 billion is spent on anti-acne medications and treatments. Representing a new paradigm in acne therapy, the ClearLight treatment penetrates just deeply enough into the skin's tissue to safely and effectively destroy Propionibacterium acnes bacteria, or P. acnes, the primary cause of acne. The clinical data submitted to the FDA examined the effects of high-intensity, narrow-band light on P. acnes bacteria and the studies concluded that ClearLight was "a promising non-invasive, non-systemic alternative to current anti-acne remedies for moderate inflammatory acne." The ClearLight technology, developed by CureLight Ltd., treats acne at its source in a very natural way. P. acnes bacteria produce porphyrins as part of its normal metabolism. The device's high-intensity light excites the porphyrins, resulting in photodestruction of the acne bacteria without damaging the surrounding tissue or skin. ClearLight treatments are quick, easy and painless, and patients have no disruption of their normal activities - an important factor for today's busy teens and young adults. Patients lie comfortably on a bed in their dermatologist's office for 15 minutes during each treatment session. The typical ClearLight treatment regimen consists of eight visits over a period of four weeks. While any area of the body that has moderate inflammatory acne can be treated, the most common areas are the face, neck, chest and back. The ClearLight system works equally well on patients of all skin colors.

 
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