Comparison of fluticasone propionate cream, 0.05%, and hydrocortisone-17-butyrate cream, 0.1%, 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 midpotency topical preparations, fluticasone propionate cream, 0.05%, and 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 blood chemical levels, hematologic analysis, urinalysis, and morning plasma cortisol levels, and by analyzing both the nature and frequency of reported adverse events. Efficacy was evaluated during the first four weeks of the study. None of the fluticasone-treated patients experienced any severe drug-related adverse events, but one hydrocortisone-17-butyrate-treated patient's eczema was severely exacerbated by drug therapy. 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 and well tolerated throughout the twelve-week study. Fluticasone cream was also found to be similar in efficacy to hydrocortisone-17-butyrate cream.

RCT Entities:   Population Interventions Outcomes