Reliant Technologies Announces FDA Clearance of FRAXEL™ Laser for the Treatment of Melasma; Embarrassing Skin Disorder Known As the Mask of Pregnancy Is Estimated To Affect Nearly 6 Million Women in the U.S

Business Wire,  July 27, 2005  

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PALO ALTO, Calif. -- Reliant Technologies today announced that the U.S. Food and Drug Administration (FDA) has cleared its breakthrough FRAXEL(TM) Laser for the specific treatment of melasma, a disturbing skin pigmentation that presents as patterns of dark brown patches on the face and is associated with pregnancy, female hormonal activity and certain drugs. Until now, the stubborn skin condition has been resistant to available therapies, with traditional laser and pulsed light treatments considered unsatisfactory due to lackluster results, significant downtime or the risk of adverse complications.

"We are delighted to finally have a successful laser treatment to offer patients who have been forced to view the world and be viewed by the world through a mask that could never be removed," says dermatology laser expert Cameron K. Rokhsar, MD, of New York, NY, who authored a landmark paper on the topic. "With the Fraxel laser's unique approach of using millions of microscopic thermal spots to gently resurface only portions of skin at a time, we can now penetrate deep enough to eliminate the melanocytes that cause melasma."

Melasma typically occurs on sun-exposed facial areas, notably the cheeks, forehead, upper lip and nose and is most common in women of child-bearing age and among male and female adults of dark-skinned races. Although the exact incidence is unknown, melasma is a very common disorder, estimated to affect about 6 million women in the United States.

"By employing fractional resurfacing with its distinctive wound healing response, we can not only resolve the excessive and undesirable pigmentation at the dermal junction, but also avoid aggravating surrounding melanocytes in order to prevent inflammatory post-treatment responses," explains study investigator Richard Fitzpatrick, MD, La Jolla, CA.

This latest FDA approval for the FRAXEL laser joins clearances obtained in 2003 for soft tissue coagulation and in 2004 for skin resurfacing and for correction of periorbital wrinkles and pigmented lesions, including age spots, sun spots and skin discoloration.

FRAXEL Laser Clinical Data on Melasma

In one study on which the FDA approval was based, marked to significant improvement of the original melasma was achieved in 70% of 10 female subjects as assessed by two independent investigators. A second well-controlled study of 10 female patients compared one half of the face that received topical therapy alone (control group) with the other half that received fractional laser treatment and topical therapy. Effectiveness was demonstrated through improvements in the appearance of melasma and quality of skin texture after laser treatment. Statistical comparisons of improvement scores showed a significant difference between the treatment groups for improvement in melasma. All subjects demonstrated some improvement in the laser treatment region compared to half of the number of subjects in the control region. No serious adverse effects were reported in the clinical studies.

About Reliant Technologies, Inc.

Reliant Technologies is a leading manufacturer of medical laser technology for aesthetic applications. The Company's laser device is used primarily by aesthetic physicians to treat periorbital wrinkles, pigmented lesions and photodamaged skin of the face and body. Reliant pioneered the development of the FRAXEL(TM) Laser which relies on new-generation fractional resurfacing with a million points of light to produce safe and effective results without interrupting patients' busy lives. Reliant employs more than 80 people and is headquartered in Palo Alto, California. For more information and physician referrals, visit www.fraxel.com.

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