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Medication formulation affects quality of life: a randomized single-blind study of clobetasol propionate foam 0.05% compared with a combined program of clobetasol cream 0.05% and solution 0.05% for the treatment of psoriasis.

Author(s): Bergstrom KG, Arambula K, Kimball AB

Affiliation(s): Department of Dermatology, Stanford University, California 94305-5334, USA.

Publication date & source: 2003-11, Cutis., 72(5):407-11.

Publication type: Clinical Trial; Randomized Controlled Trial

For topical medications commonly used to treat dermatologic conditions, outcomes may be affected by the choice of delivery vehicles. The aim of this study was to compare quality of life (QOL), effectiveness, user satisfaction, and cost-effectiveness of 2 clobetasol regimens for the treatment of psoriasis over 14 days. In a single-blind design, 32 patients randomized into 2 groups applied either clobetasol foam 0.05% to the skin and scalp or combination clobetasol cream 0.05% to the skin and clobetasol solution 0.05% to the scalp. Psoriasis severity was measured using the standardized Psoriasis Area and Severity Index (PASI) and self-administered PASI (SAPASI). QOL was assessed via the EuroQoL-5D (EQ-5D) questionnaire and Dermatology Life Quality Index (DLQI). Cost-effectiveness was measured by the amount of medication used per body surface area (BSA) treated and by cost per point improvement in PASI score. In this study, a foam formulation performed better than a cream/solution combination by several measures. A greater absolute improvement in psoriasis severity was seen in the group using the foam than in the group using the cream/solution (mean decrease in PASI=5.0 vs 3.3, P=.05). The PASI score in the foam group decreased by 41% versus 35% in the cream/solution group (P=.17). In scalp psoriasis, the group using the foam had greater improvement in both absolute (P=.03) and percentage (P=.03) terms and than the solution group. When measuring global QOL, foam users had a significantly greater increase in EQ-5D than those using the cream/solution in absolute (P=.05, P=.02) and percentage (P=.04, P=.02) terms (first and second survey components, respectively). Differences in improvement of skin-specific QOL, quantified by DLQI scores between groups, were suggested but not statistically significant. Patients using foam spent less time applying medication compared with previous topical medications (P<.001). No significant difference in cost was appreciated between foam and cream/solution over the period after controlling for BSA (8.18 dollars vs 7.05 dollars per percentage BSA affected, P=.30).

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