Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T96-02 Ivy Fleischer Kupec January 2, 1996 (301) 443-3285
The Food and Drug Administration has approved for marketing the prescription product Renova -- 0.05% tretinoin emollient cream -- as a treatment to assist in reducing certain kinds of skin damage, such as fine wrinkles, spotty discoloration and rough skin. The following can be used to answer questions:
Renova is marketed by Ortho Pharmaceutical Corp. and is the sister product to another Ortho product Retin-A, which was approved in 1971 for treating acne.
Renova was approved for the treatment of damaged skin as an adjunctive agent to a comprehensive skin care and sun-avoidance program. Its effectiveness is dependent on other good skin care practices including avoiding direct sunlight, applying sunscreens, wearing protective clothing and using moisturizing lotions. Many people can enhance skin appearance and protect skin from damage by adopting regular use of these practices and not using Renova.
Studies on Renova showed that after 24 weeks approximately 30 percent of people who used the product for fine wrinkles or spotty discoloration had moderate improvement, 35 percent had minimal improvement and 35 percent had no improvement. Among individuals who used the product, about 16 percent had moderate improvement in skin roughness, 35 percent saw minimal improvement and 49 percent had no improvement.
Renova does not eliminate wrinkles or repair the sun-damaged skin that leads to cancer. Nor is there evidence that Renova treats coarse skin, deep wrinkles, skin yellowing or other skin problems.
When patients use Renova, improvement in fine wrinkling, spotty skin discoloration and rough skin occurs gradually over time. Generally, patients notice some effect in three to four months, with the most noticeable effects at about six months. Little additional improvement is expected after that time. If Renova treatment is stopped, the improvements attained by treatment gradually diminish.
The safety of using Renova daily for more than 48 weeks has not been established, and Renova should not be used on patients who are pregnant or attempting to become pregnant. Renova has not been studied in people who are age 50 or older or in people with moderately or darkly pigmented skin.