December 9, 2002

The ClearLight device’s high-intensity light excites the porphyrins, resulting in photodestruction of the acne bacteria without damaging the surrounding tissue or skin.U.S. teenagers and adults who suffer from acne are now able to benefit from a new Israeli-developed treatment using light therapy technology.

The US Food and Drug Administration (FDA) has approved the ClearLight device, which produces a high-intensity, ultraviolet-light-free, narrow-band blue light that causes acne bacteria to self-destruct – all without damaging surrounding skin or tissue. Clearlight is produced by Curelight, a daughter company of Lumenis LTD of Yokneam, Israel, and is the first such device to win FDA approval.

“Acne often causes social withdrawal, depression and embarrassment, which can have a devastating effect on self-esteem and self-confidence,” says dermatologist A. R. Shalita, M.D. of SUNY Downstate Medical Center in Brooklyn, NY, one of the world’s leading acne experts, who led the ClearLight clinical trials leading up to the FDA approval. “ClearLight is an important new treatment for acne. It’s effective, painless and, most importantly, has no known side effects.”

Acne is a disorder resulting from the action of hormones on the skin’s oil glands (sebaceous glands), which leads to plugged pores and outbreaks of lesions commonly called pimples or zits. Acne lesions usually occur on the face, neck, back, chest, and shoulders.

Nearly 17 million people in the United States have acne, making it the most common skin disease. Although acne is not a serious health threat, severe acne can lead to disfiguring, permanent scarring, which can be upsetting to people who are affected by the disorder.

The US market for acne remedies exceeded $1.1 billion in 2001 and is the most rapidly growing therapeutic category in the dermatology sector.

The Clearlight system, now on the market in the United States, is based on photoclearing technology, which uses intensive light rays to destroy acne bacteria. Treatment with the product requires eight visits of 15 minutes each over a month, and the makers say the cure is permanent.

“Studies indicate about 40% of acne bacteria are resistant to antibiotics,” according to Alon Maor, executive vice president of Lumenis’ Aesthetic Division. “And some treatments are now associated with very severe side effects. The ClearLight solution is designed as an attractive alternative to acne sufferers.”

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 average cost of treatment ranges from $500 to $1,000.

The ClearLight device’s high-intensity light excites the porphyrins, resulting in photodestruction of the acne bacteria without damaging the surrounding tissue or skin. “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 M.D., a New York City-based dermatologist who has been using the ClearLight device.

CureLight began using the ClearLight treatment on patients two and a half years ago, conducting clinical trials on 500 people and treating thousands more in private practice.

Dermatologists from the Kinki University School of Medicine in Osaka, Japan wrote in the Journal of Dermatalogical Science this year that the therapy proved effective in 18 of 26 patients for at least one month

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