Answers
02/04/1988

<TITLE>Experimental Use of Retin-A </TITLE>
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February 4, 1988
                         EXPERIMENTAL USE OF RETIN-A
    FDA has received numerous inquiries about tretinoin (Retin-A), a topical
drug approved for treating acne.  These inquiries result from publication of
a clinical study suggesting that the drug may be useful in temporarily
reversing photoaging (premature wrinkling of the skin due to sun damage). 
    The following may be used to answer questions.
    Tretinoin, manufactured by Ortho Pharmaceutical Corp. of Raritan, N.J., 
has been available by prescription for acne since l97l.  A report in the
Jan. 22, l988, Journal of the American Medical Association conducted by 
Jonathan S. Weiss, M.D., and colleagues at the University of Michigan 
Medical Center in Ann Arbor described a l6-week, double-blind study of
tretinoin cream to treat sun-related skin aging in 30 patients. 
    According to the investigators, all 30 patients showed statistically
significant improvements in sun-related skin damage on their
tetrinoin-treated forearms, compared with forearms treated with a drug-free 
cream.  The scientists also indicated that improvement was seen in l4 of the
l5 patients who used tretinoin on their faces.
    Tretinoin is one of a number of vitamin A-derived compounds called
retinoids.  Other vitamin A-derived drugs and even vitamin A itself are 
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known to be associated with birth defects, though birth defects are not 
known to be a problem with vitamin A topical products.
    Clinical trials of the drug's safety and effectiveness for photoaging 
are being conducted under an investigational new drug exemption (IND) 
held by Ortho and will be evaluated by FDA when the company submits a new 
drug application (NDA) for this additional indication.
    In general, physicians can prescribe an approved drug for an unapproved 
use, but many doctors and patients prefer to await the completion of
clinical trials and the formal FDA review process before prescribing or 
using a prescription drug for a new use.
    FDA Commissioner Young advises that consumers should be reminded that no
drug is without side effects.  In the case of tretinoin, it is known to 
cause redness, blistering, severe local swelling, peeling and 
photosensitivity in some patients.  Also, the possible carcinogenic effects 
of its use over prolonged periods of time have not been evaluated.
    The current labeling advises: 
    "Long-term animal studies to determine the carcinogenic potential of
tretinoin have not been performed.  Studies in hairless albino mice suggest 
that tretinoin may accelerate the tumorigenic potential of ultraviolet
radiation." 
    The labeling also cautions that:
    "Concomitant topical medication, medicated or abrasive soaps and
cleansers, soaps and cosmetics that have a strong drying effect, and
products with high concentrations of alcohol, astringents, spices or lime 
should be used with caution because of possible interaction with tretinoin."
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