New Treatment for Facial Wrinkles!

FDA Approves New Product for Facial Wrinkles

The United States Food and Drug Administration (FDA) on December 12, 2003 approved an injectable gel to treat facial wrinkles.

Studies conducted by the manufacturer showed that the gel, which is called Restylane, is safe and effective for filling moderate to severe wrinkles around the nose and mouth. Most patients needed one injection to get optimal correction; about one-third of patients needed more than one injection to get a satisfactory result. The effect lasted about six months. Restylane is made with hyaluronic acid.

Two other injectable products are approved by FDA for treating wrinkles. Collagen injections are approved for correcting soft tissue deficiencies such as wrinkles and acne scars, and botulinum toxin (botox) is approved for treating frown lines between the eyebrows.

Other treatments for wrinkles include topical creams, chemical peels and laser and electro-surgical resurfacing.

FDA's approval of Restylane is based on a review of the clinical studies conducted by the manufacturer and on the recommendation of the General and Plastic Surgery Devices Panel of FDA's Medical Devices Advisory Committee.

In the pivotal study, conducted at six medical centers in the United States, 138 patients with naso-labial folds were injected with Restylane on one side of the face and Zyplast, a bovine collagen product, on the other side of the face. Most of the patients were caucasian women who did not smoke and had minimal previous sun exposure.