title: A review of two controlled multicenter trials comparing 0.05% halobetasol propionate ointment to its vehicle in the treatment of chronic eczematous dermatoses.
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 less than or equal to 0.0013) and 14 (p less than 0.0001); in study B, severity scores on days 3 (p less than or equal to 0.045, pruritus, erythema, and overall lesion severity), 7, and 14 (p less than 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 less than 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.
authors.affiliation: Department of Dermatology, University of Pennsylvania School of Medicine, Philadelphia.
authors.forename: C A
authors.initials: CA
authors.lastname: Guzzo
authors.forename: J S
authors.initials: JS
authors.lastname: Weiss
authors.forename: H S
authors.initials: HS
authors.lastname: Mogavero
authors.forename: C N
authors.initials: CN
authors.lastname: Ellis
authors.forename: N
authors.initials: N
authors.lastname: Zaias
authors.forename: N J
authors.initials: NJ
authors.lastname: Lowe
authors.forename: F A
authors.initials: FA
authors.lastname: Kerdel
authors.forename: J J
authors.initials: JJ
authors.lastname: Milbauer
authors.forename: J D
authors.initials: JD
authors.lastname: Bernhard
authors.forename: C
authors.initials: C
authors.lastname: Whitmore
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003872:Dermatitis / Q000188:drug therapy*; D003876:Dermatitis, Atopic / Q000188:drug therapy; D004485:Eczema / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009450:Neurodermatitis / Q000188:drug therapy; D009824:Ointments; D014677:Pharmaceutical Vehicles; D012074:Remission Induction; D012449:Safety; D016896:Treatment Outcome; D014481:United States; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D009824:Ointments; D014677:Pharmaceutical Vehicles; D014662:Vasoconstrictor Agents; C064466:halobetasol; D002990:Clobetasol