A review of two controlled multicenter trials comparing 0.05% halobetasol propionate ointment to its vehicle in the treatment of chronic eczematous dermatoses Article

cited authors

  • Guzzo, CA; Weiss, JS; Mogavero, HS; Ellis, CN; Zaias, N; Lowe, NJ; Kerdel, FA; Milbauer, JJ; Bernhard, JD; Whitmore, C; Urbach, F; Loder, JS; Gibson, JR

fiu authors

abstract

  • The efficacy and safety of 0.05% halobetasol propionate ointment were evaluated in patients with chronic atopic or other eczematous dermatoses in two vehicle-controlled, double-blind studies: a paired-comparison study in 124 patients (study A) and a parallel-group study in 100 patients (study B). In study A, patients applied both treatments twice daily for 2 weeks and were evaluated by investigators on days 0, 7, and 14 with 0 to 3 severity scales and by self assessment with two 5-step end-of-treatment rating scales. In study B, patients applied treatments twice daily for 2 weeks, and investigators made evaluations on days 0, 3, 7, and 14 with 0 to 6 scales and also made a 5-step end-of-treatment physician's global assessment. In study A, both severity scores and patient ratings favored halobetasol propionate significantly on days 7 (p ≤ 5 0.0013) and 14 (p < 0.0001); in study B, severity scores on days 3 (p < 0.045, pruritus, erythema, and overall lesion severity), 7, and 14 (p < 0.001, all comparisons) also favored halobetasol propionate significantly, and global assessments showed complete resolution or marked improvement for 83% of patients using halobetasol propionate versus 28% of those using vehicle (p < 0.0001). No instances of systemic effects or skin atrophy were reported in either study. We conclude that 0.05% halobetasol propionate ointment is highly effective and well tolerated in the treatment of the conditions studied, with the rapid action and high degree of clearing associated with superpotent corticosteroid formulations. © 1991, American Academy of Dermatology Inc. All rights reserved.

publication date

  • January 1, 1991

Digital Object Identifier (DOI)

start page

  • 1179

end page

  • 1183

volume

  • 25

issue

  • 6