Despite the Hype, No Elixirs of Youth

Lots of products promise to reverse the signs of aging, while providing little or no proof that they work. Here's what you need to know

By Amy Tsao

SPECIAL REPORT COSMECEUTICALS

• The Changing Face of Skin Care

• Despite the Hype, No Elixirs of Youth

• An Ugly Truth About Cosmetics

• Slide Show: A Guide to Cosmeceuticals

Want to look your best for the holidays? Think you're in need of a more youthful appearance, but you're not willing or ready to go under the knife? You might be tempted to treat yourself to a little something at the dermatologist's office -- or at the corner drugstore. People hoping to reverse the signs of aging are increasingly looking to "cosmeceuticals," nonprescription creams, gels, and lotions that promise dramatic results.

The ugly truth is that most of the age-fighting products available for retail sale lack scientific data to support their claims. While manufacturers promise dramatic improvements, especially on wrinkles, relatively few products have been studied scientifically.

That's because the active ingredients in many popular cosmeceuticals are vitamins and plant extracts, which aren't subject to the rigors of the Food & Drug Administration's drug-approval process, consisting of controlled safety and effectiveness trials in human subjects. Indeed, most manufacturers are content to be in this blurry cosmeceutical zone, with little need –- or incentive -- to conduct expensive studies.

FEEL-GOOD PRODUCTS?

  "With a few exceptions, there's precious little good data that any of the anti-aging products sold over-the-counter are effective," says Eileen Ringel, a dermatologist based in Waterville, Me. Ringel, who's also a consultant to the FDA's dermatology board, says the only data often available are "testimonials" by users who claim they've seen or felt a change in their appearance. When studies have been done, they often lack "oversight and are poorly designed," she says.

"A lot of skin-care products have rudimentary data to show that they're effective on some level," says Richard Glogau, clinical professor of dermatology at the University of California, San Francisco. "Most are just very fancy overpriced moisturizers that make the skin feel good." (Glogau consults with several cosmeceutical makers.)

Take Avon's (AVP ) latest foray into the battle against aging. In October, it launched a new product in its popular Anew line, Anew Deep Crease, which it bills as an alternative to Botox injections. The marketing pitch: "Look stunning, not stunned."

UNDISCLOSED DETAILS.

  Avon says the gel contains hyaluronic acid (the main component of synthetic collagens) for a filling effect and a "custom" extract of a plant called portulaca for a relaxing effect. "We uncovered it on our own," says Glen Anderson, senior manager in skin-care product development, of portulaca, which Avon imports from Asia.

Avon claims that the product showed strong results. After eight weeks of use, 71% of patients tested saw improvement in their lines. That sounds impressive, but the company declines to disclose the total number of patients tested or any other study details. Anderson says Avon's legal department has the detailed results ready should the Federal Trade Commission, which monitors advertising for unfair or deceptive claims, ever ask for it.

Indeed, the products that are best supported by published, scientific data are prescription drugs like vitamin-A derivatives (Renova, Retin-A, Differin, and Avage) and FDA-approved injectable treatments, such as Botox, Hylaform, and Restylane. In the nonprescription arena, some researchers point to data suggesting that some forms of topical vitamin C may protect the skin from sun damage.

AGGRESSIVE MARKETING.

  Those, of course, are the minority. A whole universe of cosmeceutical products exist that contain a variety of plants, herbs, vitamins, and antioxidants. Alpha hydroxy acids are also popular. Others use relatively new active ingredients, like palmitoyl-pentapeptide, the basis of StriVectin-SD -- a cream that with aggressive marketing as a youth-restoring alternative to Botox -– has become a big seller in the past year. Creams containing growth factors, which are traditionally used to treat wounds and burns, are also showing up in the marketplace as youth-restoring treatments.

Consumers also may not realize that the products dermatologists hawk aren't likely to be any better than items sold on pharmacy shelves or in department stores, says Ringel. "I don't understand why dermatologists would recommend these products to patients without being able to examine a well-designed, peer-reviewed study," she says. "They might as well base their recommendations on what they heard last week on Oprah."

One silver lining in cosmeceuticals' runaway growth is that for the most part, the giant beauty-products makers won't risk the type of lawsuits that would result from products that might be proved harmful. Avon's Anderson says the company runs "a significant amount of safety testing" for toxicity and allergies. Often Avon will do "exaggerated use" tests in which the ingredient is set on a patch and driven into the skin to see if it causes adverse reactions. "These companies aren't willing to take risks on stuff that's flimsy," says Glogau. By Amy Tsao Following is a guide to the good, the bad, and the ugly among popular cosmeceutical products:

Alpha hydroxy acid

Loads of products contain alpha hydroxy acid -- chemicals derived from fruit and milk sugars. Some data suggest that they may help the appearance of aging skin by exfoliating dead cells. But they're also known to have damaging effects, including rashes, swelling, and increased sensitivity to sunlight.

After conducting its own studies, the FDA in 1994 said products containing alpha hydroxy acid are safe in concentrations of 10% or less of the product and provided the acidity is also low. Glycolic acid and lactic acid, which are forms of alpha hydroxy acid, are safe at concentrations of 30% in chemical peels, the FDA said.

Botox

Botulinium toxin type A, popularly known as Botox, works by temporarily paralyzing muscles behind wrinkled skin. For its FDA filing for cosmetic use, Botox was studied in placebo-controlled randomized clinical trials involving 405 patients with moderate-to-severe eyebrow furrows. In the group receiving Botox, after 30 days, both researchers and patients rated frown lines as improved or nonexistent. Very few patients in the placebo group saw similar improvement.

Side effects include headache, respiratory infection, flu syndrome, droopy eyelids, and nausea. Less-common effects are pain in the face, redness at the injection site, and muscle weakness. It's unknown what the impact of long-term use might be. Skeptics worry that the shots will render patients' muscles atrophied over time. It's recommended that Botox not be injected more than once every three months.

Hyaluronic acid

This is the main component of the synthetic, injected products Restylane and Hylaform. They make lips plump up and remove deep skin creases by filling the space between collagen and elastin fibers within the skin. The body absorbs the gel over time, and repeated injections are needed to maintain results.

In studies across the U.S., 138 patients with frown lines were injected with Restylane on one side of the face and with a bovine collagen product on the other side. Pain and bruising occurred in both groups, but at lower rates on the Restylane-treated side.

Hyaluronic acid is showing up as an ingredient in all kinds of lotions, but no credible data show that a topical treatment would penetrate the skin and have a beneficial effect.

Vitamin A

Prescription vitamin A creams and gels such as acne treatment Retin-A, made by Ortho Pharmaceutical, a Johnson & Johnson (JNJ ) division, may also help with the appearance of fine lines, coarse skin, and pigmentation problems. "But it's not magic," cautions Jeffrey Dover, associate clinical professor of dermatology at Yale University School of Medicine and director of SkinCare Physicians in Chestnut Hill, Mass. "Results are modest and take a long time."

Dover also cautions that products containing watered-down ingredients that sound like Retin-A (retinol, retinyl, etc.) are popular, but probably useless. (Dover consults for JNJ's Neutrogena division.)

Vitamin C

Some evidence shows that vitamin C is useful in sunscreens. "It quite surprisingly provides an enormous amount of photoprotective power," says Sheldon Pinnell, professor emeritus at Duke University. A 1992 study showed that vitamin C protected pigskin from damage caused by ultraviolet rays.

Another study co-authored by Pinnell was published in the Journal of the American Academy of Dermatology last year. It showed that topical vitamin E and C together protected pigskin better from the sun than vitamin C or E alone. (Pinnell is a consultant to Skinceuticals, a line of cosmeceuticals.)

Such data are "very exciting," says Dan Rivlin, dermatologist at Skin & Cancer Associates in Miami Beach, Fla. But he doesn't typically recommend vitamin C creams to patients since the only available studies didn't involve humans. Also, Pinnell's studies were done with a particular strength and type of vitamin C that may not be the same as those in other vitamin C products.

All the rest

Hundreds of products are presented as age-fighting remedies. And some are becoming blockbusters despite uncertainties about whether they work. Strivectin-SD, for example, is on track to becoming a $100 million product by yearend -- even though relatively little evidence of safety or effectiveness has been shown.

Klein-Becker, the maker of StriVectin-SD, insists the product works and is safe, but it declines to disclose where research of the product was published. And since this summer, the Federal Trade Commission has been investigating Klein-Becker for making unsubstantiated claims on various weight-loss products it sells.

While alleged anti-aging treatments are plentiful, what's in short supply is the evidence that they can really make you look younger. Remember, promises and proof aren't the same.

Tsao is a reporter for BusinessWeek Online in New York

Edited by Patricia O'Connell

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