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Executive Summary

UPJOHN's MINOXIDIL/RETINOIC ACID CLINICAL STUDY FOR BALDNESS is slated to be underway by March in five centers in the U.S. The eight-month study will include 200 patients. The additive effect of retinoic acid with minoxidil will be studied in comparison with minoxidil alone for the treatment of baldness and thinning hair. Retinoic acid is currently used in Rx acne treatments. The Upjohn trials are designed in part to explore results of clinical research published in the October 1986 Journal of the American Academy of Dermatology. Authored by Gail Bazzano, PhD, Nia Terasakis, MD, and Wesley Galen, MD (New Orleans), the studies showed that after one year, the combination of topical tretinoin (trans-retinoic acid) with 0.5% minoxidil resulted in "terminal hair regrowth" in 66% of subjects. Results were based on several small pilot studies conducted between 1983 and 1986. Topical tretinoin was administered alone and in combination with minoxidil to 56 subjects with androgenetic alopecia. Tretinoin alone was shown to stimulate some hair regrowth in approximately 58% of the subjects. According to the study, "tretinoin has been shown to promote and regulate cell proliferation and differentiation in the epithelium and may promote vascular proliferation. These factors are important for hair growth promotion." At a recent presentation to stock analysts in New York, Upjohn Senior VP Mark Novitch noted that an 11-center, 300-patient, 32-week study is underway in the U.S. to assess the effectiveness of minoxidil in women with alopecia or hair thinning. A similar program is beginning in Europe, Novitch added. Because the centers conducting the studies are on different schedules, it may be a couple of years before the research program is completed, an Upjohn spokesperson said. If results are promising, the firm expects to file an NDA for the new indication. Upjohn is also sponsoring U.S. studies on minoxidil for alopecia areata or patchy baldness, Novitch said. The results of studies in more than 500 patients are currently being analyzed. The company may decide to conduct further research based on the analysis.

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