COMPARISON OF FLUTICASONE PROPIONATE CREAM, 0.05-PERCENT, AND HYDROCORTISONE-17-BUTYRATE CREAM, 0.1-PERCENT, IN THE TREATMENT OF ECZEMA

This is a randomized, double-blind, parallel-group, multicenter study involving 120 patients comparing the safety and tolerability of two mi dpotency topical preparations, fluticasone propionate cream, 0.05%, an d hydrocortisone-17-butyrate cream, 0.1%, in the treatment of moderate -to-severe eczema, Safety of the study medications was determined over a twelve-week period using laboratory tests for selected fasting bloo d chemical levels, hematologic analysis, urinalysis, and morning plasm a cortisol levels, and by analyzing both the nature and frequency of r eported adverse events. Efficacy was evaluated during the first four w eeks of the study. None of the fluticasone-treated patients experience d any severe drug-related adverse events, but one hydrocortisone-17-bu tyrate-treated patient's eczema was severely exacerbated by drug thera py. Plasma cortisol monitoring revealed minimal hypothalamic-pituitary -adrenal axis suppression, Overall, the nature of drug-related adverse events in patients as young as 12 years old treated with fluticasone propionate cream, 0.05%, indicates this topical application was safe a nd well tolerated throughout the twelve-week study. Fluticasone cream was also found to be similar in efficacy to hydrocortisone-17-butyrate cream.