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Candela laser OK'd for acne

FDA approval opens promising new market of teenagers, adults

A cosmetic laser developed by Candela Corp. of Wayland that zaps away wrinkles was granted additional approval by the Food and Drug Administration yesterday for use on facial acne, advancing what dermatologists described as a promising treatment option and opening up a fresh and potentially lucrative market of teens and adults.

There are other lasers on the market for acne, but they primarily eliminate bacteria in the skin.

Candela's Smoothbeam diode laser goes the extra step of shrinking the sebaceous glands under the skin, the company and dermatologists said, reducing the amount of oil the glands produce.

Some dermatologists have already begun using the Candela laser on facial acne in so-called "off-label" treatments, which are permitted if early indications show a treatment is safe and effective. The laser was approved by the FDA for the treatment of wrinkles and back acne in 2002.

"It may be a real alternative to Accutane therapy in those individuals who can't take Accutane for whatever reason," said Arielle Kauvar, a clinical associate professor of dermatology at New York University.

Accutane, a drug produced by Roche Pharmaceuticals that is commonly prescribed for severe acne, also works by shrinking sebaceous glands and reducing oil, but it presents potentially serious side effects. It can cause birth defects if taken by pregnant women, and requires monthly pregnancy testing during treatment. There also have been accusations it can increase depression and the risk of suicide among adolescents, but Roche has denied any link.

The laser wipes out an average of 75 percent of acne lesions, Kauvar said. Recurrences, which have occurred in 10 to 20 percent of patients, were milder and less frequent than before treatment, she said.

It also benefits adults because it simultaneously smooths out old acne scars.

"The vast majority of patients do extremely well," she said.

Candela president and chief executive Gerard E. Puorro said yesterday the company estimates it can sell 20,000 Smoothbeam machines worldwide at a price of $49,000 each, making it a nearly $1 billion market.

The company's stock rose 8.81 percent on the news, to close at $21.12. The stock was trading in the $13 range in October.

"We think we have a genuine, viable alternative here," Puorro said. "As you can imagine, it's a rather large market."

Treatment, which takes place in the doctor's office, will cost approximately $250 for a course of three to five treatments, one each month, for a total of $750 to $1,250.

Six months after the last treatment, more may be needed, said dermatologists. There has not been enough experience with the machine to demonstrate how many patients need ongoing treatments, they said.

"The only drawback that I know of is it's painful," said Dr. Rox Anderson, director of the laser center at Massachusetts General Hospital and a professor of dermatology at Harvard Medical School. Anderson said he has used the laser primarily on adult women. "Most people have a long-term benefit," he said.

"Raging hormones" in teens makes it difficult to predict which adolescents or young adults need follow-up treatments, said Dr. Robert Polisky, a Chicago dermatologist and spokesman for the American Academy of Dermatology.

If an 18-year-old boy goes to college, for example, he might start eating poorly and getting stressed out over homework -- triggering a recurrence of acne that would require more laser treatment, he said.

An advantage of the laser over topical treatments and antibiotics is that parents can bring their teen to the doctor and not worry about whether the youth is adhering to a course of treatment.

"With this treatment, you take the compliance issues away," said Paul Cardarelli, Candela's marketing director.

"The lack of side effects and the lack of compliance issues are going to be what drives this."

Christopher Rowland can be reached at crowland@globe.com.

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