Risks of unoccluded topical steroids in clinical trials.

Data were reviewed on the beneficial responses and adverse reactions among 2,849 patients in 14 paired-comparison studies with eight unoccluded topical corticosteroids in six steroid-responsive dermatoses. Adverse reactions were found to be mild, transient, and, for the most part, rare. Of 5,698 treatment exposures, 249 (4.39%) adverse reactions were reported, including irritation (1.3%), itching (0.95%), burning (0.81%), dryness (0.46%), scaling (0.30%), and vesicle formation (0.16%). Other reactions occurred in less than one in 1,000 treatment exposures. No severe reactions were observed. Five subjects (0.17%) terminated treatment early because of adverse reactions. The incidence of adverse reactions to vehicle alone was 6.7%. The benefit-risk ratio for mild reactions was 17:1. Therefore, long lists of adverse reactions are inappropriate in written consent forms for prospective volunteers for clinical trials. Al alternative warning statement is proposed.