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| |  AAD: Lower Dose Tretinoin Cream As Effective, Less Irritating Than Higher Doses In For Photodamaged Skin By Ed Susman Special to DG News
ANAHEIM, CA -- July 30, 2001 -- A lower dose tretinoin cream (0.02%) appears to be as effective as a higher dose (0.05%) for as long as 12 months in treating patients with photodamaged skin. Judit Nylrady, MD, of Johnson & Johnson’s Consumer Products Worldwide, Skillman, NJ, presented the findings in a series of poster presentations at the summer scientific meeting of the American Academy of Dermatology. "These studies demonstrate long-term safety and efficacy that provides assurance for the prescription of tretinoin cream 0.02% for up to one year of daily use for the treatment of moderate to severe photodamaged facial skin." Dr. Nylrady reviewed two studies-a 24 week, double-blind, placebo-controlled trial and a 52-week, open-label, extension trial-in which more than 100 patients were enrolled. The goal of the study was to determine if the 0.02% cream was as effective as the 0.05% cream, which is frequently used in treating facial wrinkling, mottled hyperpigmentation and skin roughness. In the double-blind study, 120 Caucasian subjects-87 percent were women-were enrolled, and 113 were available for evaluation. They applied the tretinoin nightly for 24 weeks; they were then observed for 12 weeks following the six-month treatment phase before entering the extension study-108 patients agreed to continue with the treatments. When researchers examined the patients, they found that 85 percent of tretinoin patients responded favorably versus 47 percent of patients using a placebo cream. There were also favorable changes in coarse wrinkling, yellowing and skin laxity, but no differences between the groups was noted in signs of hyperpigmentation or skin roughness, Dr. Nylrady said. Improvements continued during the open-label part of the study, especially showing changes in wrinkling. "Of all the subjects who received tretinoin cream 0.02%, 78 percent showed some improvement compared with 56 percent in the vehicle (placebo) group," Dr. Nylrady said. In a companion study that compared the safety of tretinoin cream 0.02% to tretinoin cream 0.05%, researchers enrolled 25 men and women in two clinical studies, and 48 people completed the studies. "The cumulative irritation study indicates a lower irritation profile for the new tretinoin cream 0.02% compared to tretinoin emollient cream 0.05%," Dr. Nylrady said. "Further studies may be necessary to compare the irritation potential of these two products in a clinical setting." In the studies, the two week irritation score reached 65 for those using the 0.05% cream compared with a 24.5 score for those using the 0.02% cream. After three weeks, the irritation score was 200 in the higher dose, compared with 92.5 in the lower dose cream.
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