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Evidence-Based Dermatology: Research Commentary
September 2002

Treatment of Bullous Pemphigoid With Topical Corticosteroids: Review of a Randomized Controlled Trial

Author Affiliations

MichaelBigbyMDRosamariaCoronaDSc, MDDamianoAbeniMD, MPHPaoloPasquiniMD, MPHMoysesSzkloMD, MPH, DrPHHywelWilliamsMD

Arch Dermatol. 2002;138(9):1236-1237. doi:10.1001/archderm.138.9.1236

Joly and colleagues have conducted a clinical trial that has important implications for the management of patients with bullous pemphigoid. The study was a multicenter, randomized, nonblinded trial in which patients were stratified based on the severity of disease and clinical center prior to randomization. The study population consisted of consecutive patients with bullous pemphigoid based on clinical features, a subepidermal blister on skin biopsy, and linear deposits of IgG and C3 along the basement membrane zone. Patients were excluded if there was predominant or exclusive mucous membrane involvement, or if the patient had been treated with oral or topical corticosteroids, dapsone, or immunosuppressive drugs in the previous 6 months. Patients were defined as having extensive disease if they had more than 10 new bullae daily and were defined as having moderate disease if they had 10 or fewer new bullae daily. Patients were randomized to receive either topical corticosteroids or oral prednisone. Irrespective to extent of disease, patients randomized to topical corticosteroids were treated with 40 g of clobetasol propionate cream divided twice daily to the entire body surface until 15 days after control of disease was attained. Thereafter, the topical corticosteroids were gradually tapered using a defined protocol. When possible, topical corticosteroids were applied by the patients themselves or by members of their households, or a nurse performed this task for patients who were unable to do this. Patients randomized to oral treatment received 0.5 mg/kg daily and 1 mg/kg daily of prednisone for moderate and extensive disease, respectively. The initial dose was maintained for 15 days after control of disease was obtained and then was tapered using a standard protocol. The primary outcome was overall survival. The secondary outcome was disease control and relapse. The analysis was based on intention to treat. The time points for assessment of survival and the subgrouping of patients into moderate and extensive disease for analysis were prespecified, and patients were followed up for 12 months. The Karnofsky score, a measure of the patient's overall health, was used to assess the baseline risk of mortality in the treatment groups.

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