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Clinical Trials

Renova (tretinoin emollient cream)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 1995

Specific Treatments:

facial wrinkles, brown spots, and surface roughness of the skin

Therapeutic Areas

General Information

Renova .05% is a skin cream that reduces fine facial wrinkles, brown spots, and surface roughness associated with chronic sun exposure and the natural aging process when used in addition to a comprehensive skin care and sun avoidance program. Renova is an additional therapy for persons who do not achieve satisfactory results using a sunscreen, protective clothing and moisturizers alone. It does not eliminate wrinkles, repair sun damaged skin or reverse either the aging process or photoaging.

Renova contains the active ingredient tretinoin, a vitamin A metabolite that occurs naturally in the body.

While over the counter alpha hydroxy acids are thought to work primarily on the surface of the skin to remove dead skin cells and moisturize, Renova is believed to work on all layers of the skin, including the epidermis where pigmentary changes occur and even the deeper portions of the skin where fine wrinkling begins.

Clinical Results

More than 300 subjects between the ages of 30 and 50 participated in the clinical studies of Renova, which were conducted during a 48-week period at eight research centers nationwide. Subjects received treatment for up to 48 weeks with Renova or a placebo, in conjunction with a comprehensive skin care and sun avoidance program.

In the clinical trials, physicians noted some signs of skin improvement in 78% of subjects treated with Renova. 64% of subjects showed improvement in fine wrinkling, 65% showed reduction in brown spots, and 51% showed smoothing of surface roughness. In subjects treated with a placebo skin cream plus a comprehensive skin care and sun avoidance program, 38% showed improvement in fine wrinkles, 48% showed reduction in brown spots, and 33% showed smoothing of surface roughness.

Side Effects

Almost all Renova users experienced side effects before seeing visible improvement. These side effects are temporary, usually mild to moderate in severity, and may include some redness, dryness, itching, peeling, or a slight burning or tingling sensation. In clinical studies, these skin reactions were temporary and usually disappeared within a few weeks after therapy began. In most patients, the dryness, peeling, and redness recurred after an initial (24 week) decline. During these studies, only 4% of patients discontinued Renova due to adverse reactions.

However, Renova is considered to be a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks are not known. There is evidence of atypical changes in malanocytes and keratinocytes, and or increased dermal elastosis in some patients treated with Renova for longer than 48 weeks. The significance of these findings is unknown. Safety and effectiveness of Renova in individuals with moderately or heavily pigmented skin have not been established, as well.

Additional Information

Renova does not reduce coarse or deep wrinkling, skin yellowing, skin looseness, prominent blood vessels or larger areas of abnormal pigment accumulation (lentigines). It has also not been shown to affect sun-induced abnormalities in epidermal cells or skin elasticity.

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