Hydrocortisone

Hydrocortisone Butyrate 0.1% Cream in the Treatment of Chronic Dermatitis

Fowler JF, et al. Cutis. 2005; 75(2):125-131.

Summary

The authors present a double-blinded, multicenter, randomized clinical trial to assess the efficacy and cosmetic acceptability of 4 medium-potency topical corticosteroids in the treatment of chronic hand dermatitis and atopic dermatitis. The corticosteroids used were hydrocortisone butyrate 0.1% cream (HB), prednicarbate 0.1% cream (PC), fluticasone propionate 0.05% cream (FP), and mometasone furoate 0.1% cream (MF). Eighty-nine subjects were enrolled into the study and were required to have nearly symmetric bilateral cutaneous lesions. Eighty-six patients had moderate hand dermatitis and 3 patients had moderate atopic dermatitis. The mean duration of hand dermatitis was greater than 6 years. Patients were randomized to 3 treatment groups, applying HB to 1 side of the body and 1 of the other 3 corticosteroids to the other side. Patients and investigators were blinded as to treatment, the patients receiving tubes marked "left" and "right." Patients applied study medications twice daily for 2 weeks and were scored from 0 (none) to 3 (severe) at baseline and at 2 weeks regarding erythema, scaling, papules/vesicles, and fissuring/cracking. Patients also rated themselves for the above signs plus symptoms of burning, pain, and pruritus. In addition, patients completed a questionnaire, documenting which cream was most preferred, which was most soothing, and which was the better moisturizer. At the end of 2 weeks, all 4 corticosteroids showed significant decreases in scores. Improvement of fissuring/cracking was statistically significant for HB as compared to PC; however, there were no other statistically significant differences between paired treatments. Regarding the patients' sign and symptom scoring, FP did not show a statistically significant reduction; however, all other treatments showed statistically significant reductions from baseline with no significant difference between pairs. HB was rated as "more soothing" and "better moisturizing" in each treatment group. No significant adverse events were reported.

Comment

This study was designed to assess a new high-lipid formulation for hydrocortisone butyrate, Locoid Lipocream.[R] The study was supported by a grant from Ferndale Laboratories who make this medication. All corticosteroids used in this trial are of the same potency and would be expected to have similar efficacy in treating dermatitis. Indeed, difference in efficacy was not statistically significant among treatment groups. To assess the cosmetic acceptability of this new product compared with others, patients filled out a questionnaire. A higher percentage of patients in each treatment group rated HB as "more soothing" and "better moisturizing," although the percentage difference in each treatment arm ranged from less than 5% to roughly 40% in favor of HB. Locoid Lipocream[R] may be of benefit for patients who do not like ointments or are not cosmetically satisfied with other corticosteroid creams.

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