Atop the Wrinkle-Cream Heap
In the wide, wide world of wrinkle creams, one has finally distinguished itself.
A week ago, the U.S. Food and Drug Administration quietly gave formal approval for the marketing of Renova, the first prescription drug for the treatment of fine facial wrinkles caused by sun exposure. But today, with drugstore shelves crowded with nonprescription skin products, it’s uncertain just how big a splash Renova will make.
Nevertheless, it’s the only drug that can carry a legitimate claim for effectively reducing fine facial lines, brown spots and surface roughness.
The emollient cream will become available next month and will cost about $60 for a four-to-six month supply.
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Over-the-counter wrinkle products containing natural fruit acids known as alpha hydroxy acids are hot sellers. But they are considered strictly cosmetics, not drugs, by the FDA. While cosmetic manufacturers can float claims that their products reduce wrinkles, only Renova has been backed by the independent investigation of the FDA.
“I think [prescription status] sets Renova apart from the nonprescription products,” says Dr. Tabitha Henderson, senior director of clinical affairs for Ortho-McNeil Pharmaceuticals.
“It contains the active ingredient tretinoin. It’s viewed as a drug by the FDA. AHAs, on the other hand, are regulated as cosmetics. They are thought to moisturize and slough off the upper layer of the skin,” she says.
Tretinoin, a vitamin A metabolite, is thought to work on all layers of the skin, including the deeper layers where fine wrinkling begins, says Dr. James Leyden, a Pennsylvania dermatologist who tested Renova in clinical trials.
But Ortho is not exactly boastful about its new product. The label for Renova will describe it as an “adjunct” treatment for sun-damaged skin. According to Henderson, that means physicians should first counsel their patients to use sunscreens with an SPF of 15 or higher, protective clothing and moisturizers to improve skin appearance. If that proves unsatisfactory, Renova is considered appropriate.
Ortho’s restraint may be due to Renova’s interesting history. In 1971, Ortho received FDA approval to market the prescription skin cream Retin-A for acne. By the 1980s, however, Retin-A had become intensely popular as a remedy for facial wrinkles, and studies were initiated to test its efficacy for reducing wrinkles.
Ortho, however, got into hot water with federal investigators for allegedly marketing Retin-A as a wrinkle cream prematurely. The company asserted it did nothing wrong, but still paid a $7.5-million fine last year for destroying company documents central to the investigation.
Renova and Retin-A both contain tretinoin. But Renova is formulated in an emollient cream and is for “dryer, more mature skin,” Henderson says. Retin-A, which is still approved only for acne, is for oiler skin, she says.
Clinical trials on Renova showed a modest level of effectiveness: 64% of patients experienced improvement in fine wrinkling and 65% had reduced brown spots. Surface-skin roughness was reduced in about half of patients.
Ortho is taking care to describe Renova’s benefits in mild terms. Skin improves gradually, Henderson cautions, over one to six months. Improvements can only be expected if the consumer also uses a good sunscreen and avoids direct sun exposure. And, she says, results will vary among individuals.
“It’s not a wonder drug or a miracle cream,” Henderson says. “It does not reverse the aging process. It does not treat deep wrinkles or skin yellowing, deeply pigmented lesions or dilated blood vessels.” Still, she adds: “It’s a very interesting product.”
