Albert M. Kligman, M.D., Ph.D.
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In this month's installment of Dialogue with a Mentor, Dermatology Times speaks with Albert M. Kligman, M.D., Ph.D., about anti-aging. Thirty-five years ago, in his laboratory at the University
of Pennsylvania, Dr. Kligman worked to evaluate retinoic acid (tretinoin, Retin-A) for use in a new acne treatment. At the
time, he had no notion that tretinoin would be an effective topical modality for mitigating signs of photoaging. In 1984,
Dr. Kligman and colleagues were the first to report, based on an animal model, that topical tretinoin enhanced repair of dermal
connective tissue damaged by ultraviolet exposure. Of course, Dr. Kligman did not foresee that the eventual marketing introduction
of tretinoin as an adjunct for the treatment of photodamaged skin would foster development of a multibillion-dollar cosmeceutical
industry, as well as the emergence and growth of cosmetic dermatology as a new subspecialty. Dr. Kligman reflects on his discovery
of the anti-aging effects of tretinoin.
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.
A number of women also described added benefits of improvement in wrinkles, blotchiness, skin tone, and texture. At first,
I tended not to pay too much attention to those reports because I wasn't aware of any mechanism whereby tretinoin might modulate
such changes. Over time, however, as more women reported the same effects, I realized tretinoin might represent a real phenomenon
that should be documented with well-designed studies using photographic assessments, objective bioengineering techniques,
and histological evaluation. 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.
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