To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves New Formulation Of Renova (Tretinoin Cream) For Reduction Of Fine Facial Wrinkles URL: http://www.pslgroup.com/dg/1E00B6.htm Doctor's Guide September 6, 2000
SKILLMAN, N.J. -- September 6, 2000 -- The U.S. Food and Drug Administration (FDA) has approved Renovaź (tretinoin cream) 0.02%, a new formulation of the only prescription cream proven to reduce fine facial wrinkles associated with chronic sun exposure and the natural aging process. The new Renova formulation, in a cosmetically elegant cream, is effective in reducing fine facial wrinkles when used as part of a total skin care and sun protection program. Marketed by Ortho Dermatological, a member of the Johnson & Johnson Family of Companies, it will be available by prescription in November 2000. "Physicians now have two FDA-approved options to offer the millions of people who want to improve the appearance of their photodamaged skin," says Robert Armstrong, M.D., Vice President, Medical Affairs, Johnson & Johnson Consumer Products Worldwide. Studies demonstrate that nightly therapy with Renova 0.02% significantly improves fine facial wrinkles, such as crow's feet. Renova (tretinoin cream) 0.05%, approved by FDA in 1995, is proven to reduce fine facial wrinkles, fade brown spots and smooth surface roughness. Renova 0.02% contains the active ingredient tretinoin (a Vitamin A derivative like the one naturally occurring in the body), in a light, oil-in-water cream. Research shows that tretinoin acts deep at the cellular level and increases the level of pro-collagen I. Researchers believe this is one reason why Renova is effective in reducing the signs of aging. "Renova 0.02% is an ideal starter product for the person who is serious about improving the appearance of their skin," says William D. Cordivari, president, Ortho Dermatological. "Patients should discuss with their doctors which Renova formulation is appropriate for their skin." Six-hundred-and-fifty-six subjects between the ages of 45 and 70 who showed signs of moderate to severe photodamage participated in the randomized, multi-center, double-blind, clinical studies for Renova 0.02%. Subjects received treatment for up to 24 weeks with Renova 0.02% or a placebo, in conjunction with a comprehensive skin care and sun protection program. Based on investigator evaluations, subject self-assessments and independent computer-generated skin replica measures, Renova 0.02% exhibited significantly better improvement than placebo in treating fine facial wrinkles in Caucasian and other lightly-pigmented subjects. People who respond to Renova 0.02% Cream may begin to notice their skin becoming smoother and softer within the first month or two. Within two to three months, users may notice a reduction in fine facial wrinkles. Additional benefits should be apparent within five to six months of therapy. Continued use of the product beyond six months can help maintain the visible improvement. People who discontinue Renova therapy for more than 12 weeks may lose some of the product's effects. Once therapy is restarted, users should continue to see improvement. "People using Renova generally experience some redness, itching, dryness, or flaking before seeing visible improvement," explains Dr. Armstrong. "These signs and symptoms are usually mild and well tolerated and decrease as treatment continues." Like other prescription medications, Renova 0.02% Cream has been tested for safety and effectiveness. While it will not repair sun damaged skin, eliminate wrinkles, or reverse the aging process, it is proven to reduce fine facial wrinkles. When using Renova, as with any other anti-aging or skin-care product, you should limit exposure to the sun and always use a sunscreen. Renova Cream 0.02% is a dermal irritant. It has been proven effective in clinical trials lasting 52 weeks in Caucasians and other lightly-pigmented subjects. Effectiveness beyond 52 weeks has not been established in controlled clinical trials. Renova Cream 0.05% has been proven effective in clinical trials lasting 48 weeks in Caucasians 30-50 years old. Clinical trials in those over 50 or with moderately or heavily pigmented skin have not been conducted. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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