Home » Drug Information » FDA Approved Drugs » 1995
Medical Areas: Dermatology
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Renova (tretinoin emollient cream)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Johnson & Johnson
Approval Status: Approved December 1995
Treatment Area: facial wrinkles, brown spots, and surface roughness of the skin
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.
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
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.
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