FDA approves Fraxel for melasma treatment

September 6, 2005

Palo Alto, Calif. -- The Food and Drug Administration (FDA) has approved Fraxel, a skin-resurfacing laser device manufactured by Reliant Technologies, for use in the treatment of melasma associated with pregnancy, female hormonal activity and certain drugs.

Palo Alto, Calif. -- The Food and Drug Administration (FDA) has approved Fraxel, a skin-resurfacing laser device manufactured by Reliant Technologies, for use in the treatment of melasma associated with pregnancy, female hormonal activity and certain drugs.

According to a statement issued by Reliant, melasma is resistant to traditional therapies and traditional laser and pulsed-light treatments are considered unsatisfactory because of poor results, significant downtime or the risk of adverse events.

The statement said the FDA's approval of Fraxel to treat melasma was based in part on a study showing that use of the device resulted in significant improvement of melasma in seven of 10 female patients assessed by two independent investigators. In a second 10-patient study, facial areas treated with the device showed statistically significant improvements in the appearance of melasma and quality of skin texture, as compared with use of topical therapy alone. No serious adverse events were observed in any of the studies.