September 1, 2004

Albert M. Kligman, M.D., Ph.D.'s 'accidental' discovery of tretinoin moved drug well beyond acne treatment

Q What prompted you to study the use of tretinoin for the treatment of photo- and intrinsically aged skin?

After tretinoin was introduced, females in their 30s and 40s who were using it to treat their post-adolescent acne told me that they were pleased with its efficacy for controlling their acne outbreaks.

Q What is your opinion about the effectiveness and side effects of other retinoids, i.e., adapalene (Differin) and tazarotene (Avage), to treat photo-aged skin?

All of the topical retinoids effectively treat actinically damaged skin. Relative to tretinoin, adapalene is somewhat less irritating but also a little less effective, whereas tazarotene is more effective but causes more irritation.

Women who are prescribed these topical retinoids must be informed that the responses are achieved slowly and it can take many months before they notice any improvement. However, the benefits can be sustained long-term with continued treatment.

It is also important to differentiate the topical retinoids from "wrinkle cream" products containing vitamin A derivatives that are sold without prescription. Those formulations, which contain such compounds as vitamin A palmitate, really don't work.

Q Cosmeceuticals fall outside the boundary of the FDA. As a result, there is no requirement for their manufacturers to conduct well-controlled clinical trials to demonstrate product efficacy and safety. What impact does that have on the credibility of their claims?

These products can't make claims that they reverse or prevent the effects of aging, but their marketing can include statements about benefits to skin appearance or texture.

That limitation has certainly not hampered growth of the anti-aging cosmeceutical market. Currently, it is at least a $35 billion annual business, and it is continuing to grow rapidly as aging American women with lots of disposable income are flocking to the stores for products offering eternal youth. Ninety percent of those products have no effects whatsoever, whereas women who visit a well-trained dermatologist are likely to receive intervention that works.

Q Do you anticipate any effort by the FDA to regulate cosmeceuticals?

I don't see that they should. If these products are not making any claims about anti-aging benefits or effects on structure or function of the skin, then their marketing is outside of the domain of the FDA.

Furthermore, I would object if they did. I see no need for moisturizers or other skincare products to be regulated. There are also downsides to regulation. Of course, we may need to be concerned about entities introduced by fly-by-night companies, but there are a lot of well-established, reputable cosmeceutical manufacturers that conduct adequate testing of their products' efficacy and safety. Greater FDA regulation might introduce economic constraints that would be a disincentive to research and development.