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.
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000188:drug therapy; D003877:Dermatitis, Contact / Q000188:drug therapy; D004311:Double-Blind Method; D005260:Female; D005447:Fluocinonide / Q000009:adverse effects; D005938:Glucocorticoids; D006206:Halcinonide / Q000009:adverse effects; D006801:Humans; D008297:Male; D011565:Psoriasis / Q000188:drug therapy; D012871:Skin Diseases / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D005447:Fluocinonide; D006206:Halcinonide