fluticasone and hydrocortisone-17-butyrate

The efficacy, safety, and tolerability of twice-daily fluticasone propionate (Cutivate) cream, 0.05%, and hydrocortisone-17-butyrate cream, 0.1%, were compared in 125 patients with moderate-to-severe psoriasis in a 4-week, multicenter, double-blind, randomized, active-control study. Clinical assessments of response to therapy, made at weekly intervals, included physicians' gross assessment of clinical response, improvement in signs and symptoms, and patients' assessment of treatment effects. Based on physicians' gross assessment, fluticasone propionate cream was superior to hydrocortisone-17-butyrate cream at day 22 (after 3 weeks' treatment) and at the end-of-treatment visit (P < .05). Cleared, excellent, or good end-of-treatment response rates were 50/63 (79%) for fluticasone propionate compared with 41/60 (68%) for hydrocortisone-17-butyrate. Adverse events were limited to mild-to-moderate pruritus with fluticasone propionate (3.2%) and hydrocortisone-17-butyrate (1.7%) and mild skin warmth with hydrocortisone-17-butyrate (1.7%).

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Humans; Hydrocortisone; Male; Middle Aged; Ointments; Psoriasis; Skin

The efficacy and safety of twice-daily topical application of fluticasone propionate ointment, 0.005%, and hydrocortisone-17-butyrate ointment, 0.1%, were compared in 113 adult patients with moderate-to-severe psoriasis in a multicenter, double-blind, randomized, parallel study. The majority of patients had psoriatic involvement of long duration over a large body surface area (mean, 17%). The following efficacy assessments were made at weekly intervals for up to four weeks following initiation of treatment: physician's gross assessment of clinical response of the target lesion; severity of psoriatic signs and symptoms; and patients' assessment of treatment effects. Safety was assessed by monitoring and reporting any adverse events that occurred during the study. Fluticasone propionate ointment, 0.005%, was found to be therapeutically superior to hydrocortisone-17-butyrate ointment, 0.1%, as well as safe and well tolerated. Its onset of action was rapid and no systemic adverse effects occurred. Overall patients experienced progressive improvement with fluticasone propionate ointment, 0.005%.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Androstadienes; Anti-Inflammatory Agents; Double-Blind Method; Drug Administration Schedule; Female; Fluticasone; Humans; Hydrocortisone; Male; Middle Aged; Ointments; Psoriasis

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.

Topics: Administration, Topical; Adolescent; Adult; Aged; Androstadienes; Anti-Inflammatory Agents; Child; Double-Blind Method; Drug Administration Schedule; Drug Tolerance; Eczema; Female; Fluticasone; Humans; Hydrocortisone; Male; Middle Aged; Ointments; Safety