The gel is the third injectable wrinkle treatment to gain approval from the agency. Botox (botulinum toxin) is approved for treating wrinkles between the eyebrows, and collagen injections are approved for filling other types of wrinkles and skin imperfections.
New Wrinkle Fighter
Restylane is made with hyaluronic acid, which is a substance normally found in the skin that adds volume and fullness to the skin.
The FDA based its approval on the results of a clinical trial of 138 patients in the U.S., with nasolabial folds, who were treated with Restylane on one side of the face and a collagen injection (Zyplast) on the other.
Researchers found that six months after treatment, the effects of Restylane and Zyplast as wrinkle fillers were comparable. Most patients needed one injection to get the desired effects, but about one-third required more than one injection to get satisfactory results.
Within 14 days following the first treatment, the Restylane treated side had a lower rates of severe redness and an increased incidence of severe bruising, severe swelling, severe pain, and severe tenderness compared with the Zyplast treated side. With follow-up treatment, fewer patients in both treatment groups reported these side effects. Most of the people involved in the study were white women who did not smoke and had minimal previous sun exposure.
The FDA says little is known about the safety of Restylane in non-whites. The product's maker, Q-Med AB of Sweden, has agreed to conduct a postapproval study on people of color to address this issue.
Since 1996, Restylane has been used in more than 60 countries. Medicis Aesthetics will market Restylane in the U.S.