Lumenis (Nasdaq: LUME), a developer of laser devices for medical applications, announced on Monday that the US Food and Drug Administration had approved its ClearLight system for moderate inflammatory acne vulgaris.
The ClearLight Acne PhotoClearing system uses high-intensity, narrow-band phototherapeutic light to destroy the bacteria that cause acne.
Lumenis' Aesthetic Division executive vice president Alon Maor said, "ClearLight is a non-drug alternative that's easy and effective, and, with no known side effects, this treatment device will surely allow more acne sufferers to enjoy the benefits of clear skin. ClearLight was launched in Canada, Europe and Japan last year, and has caused a great deal of excitement among both dermatologists and acne sufferers."
"Studies indicate about 40% of acne bacteria are resistant to antibiotics," Maor said. “And some treatments are now associated with very severe side effects. The ClearLight solution is designed as an attractive alternative to acne sufferers."
Yokneam-based Lumenis says acne affects more than 80% of the world's population at some time during their life. In the US, more than $1.4 billion is spent on anti-acne medications and treatments.
The multi-center ClearLight clinical trials were led by dermatologist A.R. Shalita, MD of SUNY Downstate Medical Center in Brooklyn, NY. "ClearLight is an important new treatment for acne. It's effective, painless and, most importantly, has no known side effects," Dr. Shalita said.
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," Lumenis said.
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.
The ClearLight technology was developed by CureLight, founded in 1999 by Dr. Yoram Hart and Avner Korman. CureLight is currently developing additional systems for treatment of other skin ailments.
"Just exposing the patient's skin to this high-intensity light for 15 minutes will result in the elimination of bacteria that cause acne," said Macrene Alexiades-Armenakas MD, a New York City-based dermatologist who has been using the ClearLight device.
ClearLight treatments are quick, easy and painless, and patients have no disruption of their normal activities. Patients lie 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. Lumenis says the system works equally well on patients of all skin colors,.
In the clinical study, researchers found ClearLight to be an effective method of reducing moderate inflammatory acne lesions. All patients were treated twice a week for four weeks, then followed monthly for an additional three months. Clearing of inflammatory acne was observed to continue throughout the follow-up period. After eight semi-weekly treatments, patients with moderate acne showed significant improvement and no side effects were noted. "Study participants were very satisfied with the clarity of their skin after undergoing ClearLight therapy," Dr. Shalita said.
Published by Globes [online] - www.globes.co.il - on 20 August, 2002