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Executive Summary

ORTHO's RETIN-A IS IN PHASE III CLINICALS INVOLVING 2,000 PATIENTS with photodamaged skin. The studies are underway at six U.S. centers, the firm said, to support a planned NDA filing this year for the product's use in treating photo-aged skin with symptoms of wrinkling, blotching and loss of elasticity. Retin-A is currently approved and marketed as a prescription anti-acne cream. The first published study of Retin-A's ability to improve photodamaged human skin in a controlled clinical trial appeared in the Jan. 22/29 issue of the Journal of the American Medical Association. The article reported results of a four-month, 30-patient study, conducted at the University of Michigan Medical Center. The Michigan study was partly funded by Ortho. The double-blind, randomized, vehicle-controlled study of 30 patients aged 35-70 found that with as little as two weeks of treatment with 0.1% Retin-A cream, 5%-10% of the study group's skin showed improvements, especially in "fine wrinkling." By four weeks, the tretinoin-treated forearms of 50% of the patients and the faces of 53% were improved. In addition to marked improvements in fine wrinkling for both treated areas, "coarse wrinkling" was improved in 40% of the treated faces and "tactile roughness" in 33%. "Significant" improvements in those characteristics were reported for the patients' forearms. Both treated areas also showed "increased pinkness" described by the patients as a "rosy glow." Dermatitis was experienced by 92% of the study group "to some degree," the study reports. The adverse reactions occurred from two days to 10 weeks after the treatment had started and lasted from three weeks to two months, according to the study. Discontinuation of Retin-A applications for several days and the application of emollients alleviated the symptoms. The researchers believe that Retin-A speeds up the production of new cells and promotes the development of the underlying layers of skin, which tend to become thinner with age or damage from sun exposure. The researchers found that biopsied tretionoin-treated forearm skin samples showed an increase in mean epidermal thickness of 273%. After 12 weeks, the researchers found that all the tretinoin-treated forearms and 93% of the patients with Retin-A treated faces "showed at least slight improvement." Continued improvement in most patients was seen through the end of the study, the researchers note. However, they question whether effects observed in the study can be sustained. Ortho attracted a tremendous amount of lay media attention to Retin-A at a Jan. 21 press conference announcing the results of the Michigan study. One possible outcome might be an immediate increase in Retin-A sales for the unapproved indication. The public excitement prompted Ortho parent Johnson & Johnson to issue a release on Jan. 22 stressing that the study was preliminary and that Retin-A has not been proven to have an effect on chronically aged skin.

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