Skin Care
FDA Approves New Product for Facial Wrinkles
The Food and Drug Administration (FDA) approved an injectable gel to
treat facial wrinkles.
Studies conducted by the manufacturer showed that the device, 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
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 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.
The results showed that, six months after treatment, the effects of Restylane
and Zyplast as wrinkle fillers were comparable.
As reported by patients within 14 days following the first treatment, the Restylane
treated side had a lower incidence of severe redness (5.1% vs. 5.8) and an increased
incidence of severe bruising (3.6% vs. 0.7%), severe swelling (3.6% vs. 1.4%),
severe pain (3.6% vs. 1.4%), and severe tenderness (2.9% vs. 1.4%) compared
with the Zyplast treated side. These incidents were lower with follow up injections
for both products.
There was limited data in the study on the safety of Restylane in non-caucasians.
The firm, Q-Med AB of Sweden, has agreed to conduct a post approval study in
people of color to determine the product’s safety for this population.
The firm will also provide training to physicians on the correct use of the
device.
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