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A review of two controlled multicenter trials comparing 0.05% halobetasol propionate ointment to its vehicle in the treatment of chronic eczematous dermatoses.
- Source :
-
Journal of the American Academy of Dermatology [J Am Acad Dermatol] 1991 Dec; Vol. 25 (6 Pt 2), pp. 1179-83. - Publication Year :
- 1991
-
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.
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Chronic Disease
Clobetasol administration & dosage
Clobetasol adverse effects
Clobetasol therapeutic use
Dermatitis, Atopic drug therapy
Female
Humans
Male
Middle Aged
Neurodermatitis drug therapy
Ointments
Pharmaceutical Vehicles
Remission Induction
Safety
Treatment Outcome
United States
Vasoconstrictor Agents administration & dosage
Vasoconstrictor Agents adverse effects
Clobetasol analogs & derivatives
Dermatitis drug therapy
Eczema drug therapy
Vasoconstrictor Agents therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0190-9622
- Volume :
- 25
- Issue :
- 6 Pt 2
- Database :
- MEDLINE
- Journal :
- Journal of the American Academy of Dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 1757614
- Full Text :
- https://doi.org/10.1016/0190-9622(91)70322-s