New product for treating facial wrinkles

FDA Consumer, March-April, 2004

Restylane (hyaluronic acid), approved by the FDA in December 2003, is the third injectable product available to treat facial wrinkles. Restylane is different than the other approved products in that its effects last longer, about six months.

Studies showed that Restylane, classified as a medical device by the FDA, is safe and effective for filling moderate-to-severe wrinkles around the nose and mouth. Most people needed one injection to get optimal correction, while about one-third of people tested needed more than one injection to get a satisfactory result.

The two other injectable products approved by the FDA are collagen injections for correcting soft tissue deficiencies such as wrinkles and acne scars, and botulinum toxin (Botox Cosmetic) for treating frown lines between the eyebrows. The effects of both treatments last as long as four months.

Restylane is manufactured by Q-Med AB of Uppsala, Sweden.