FDA Approves New Product for 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.
About the Author
Dean Brown's website can be found at http://nowrinkles.babymyskin.com
Importance Of Shower Filters
Are you sure that taking a shower ensures your cleanliness and protection against the germs and bacteria moving around in the atmosphere? Not really? Nowadays, shower filters are gaining popularity to maintain the cleanliness and appropriate consumable water to protect us from various ailments and...
Acne and the liver
One of the major causes of acne is hormone imbalance. The first part of balancing your hormones is by regulating their production. The second part to balancing your hormones is by effectively removing used up hormones from the body via the liver. Both parts play a...
Guide to Natural Acne Treatments
Acne is a problem for many people. There are a variety of products that are designed to get rid of or reduce acne. However, many people do not know that there are natural ways to reduce acne, or completely eliminate it. The best way to naturally get rid of pimples is to consider the causes of...