Treatment of Mild-to-Moderate Chronic Hand Dermatitis With Clobetasol Propionate 0.05% EF Foam: Results From an Open-Label Study
December 2011 | Volume 10 | Issue 12 | Original Article | 1398 | Copyright © 2011
Leon H. Kircik MDa,b and Cathy Tropmann RPhc
aMount Sinai Medical Center, New York, NY bPhysicians Skin Care, PLLC, Louisville, KY cStiefel, a GSK company, Research Triangle Park, NC
Objective: To assess the safety and efficacy of clobetasol propionate 0.05% emulsion formulation (EF) foam in subjects with mild-to-moderate chronic hand dermatitis.
Methods: This was a single-center, open-label pilot study of 30 adults with chronic hand dermatitis. Subjects were treated with clobetasol propionate 0.05% EF foam twice-daily and returned for assessment at day 8 and day 15. The primary efficacy endpoint was the proportion of subjects who achieved treatment success, defined as improvement of ≥1 grade in their chronic hand dermatitis as per the Investigator's Static Global Assessment (ISGA) from baseline to day 15. Safety and quality-of-life measures were also assessed.
Results: A minimum 1-grade improvement in the ISGA was achieved by 96.7 percent (29/30) of subjects at day 15, with 80 percent (24/30) of subjects achieving a score of 0 (clear) or 1 (almost clear). Clobetasol propionate 0.05% EF foam appeared to be safe and well-tolerated, with only four subjects experiencing treatment-related adverse events. No pattern of adverse event occurrence or predisposition could be delineated from this study.
Conclusion: Clobetasol propionate 0.05% EF foam appeared to be safe and effective for the treatment of chronic hand dermatitis.
J Drugs Dermatol. 2011;10(12):1398-1402.
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Hand dermatitis is considered to be quite common, and it is estimated that between two percent and 10 percent of the general population is affected by this skin condition.1 Hand dermatitis often follows a course of remittance and relapse, and chronic hand dermatitis cases are often treated with a topical corticosteroid in an ointment or cream formulation, in addition to skin protection and emollients.2 Corticosteroids are a mainstay of therapy; however, treatment effectiveness is just one of the main challenges for this disease. It has been shown that quality of life is considerably impaired by those who suffer from chronic hand dermatitis.3
Clobetasol propionate is a commonly prescribed corticosteroid, and is available in a variety of formulations. Clobetasol propionate 0.05% in an emulsion formulation (EF) foam is indicated for the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses and has been demonstrated to be safe and effective for the topical treatment of moderate-to-severe atopic dermatitis,4-6 which is an important contributor in the development and persistence of hand dermatitis.1,2. In a study of 377 patients with moderate-to-severe atopic dermatitis,6 59 percent of patients treated with clobetasol propionate 0.05% foam achieved treatment success (Investigator's Static Global Assessment [ISGA] score of 0 or 1) versus 16 percent with placebo after two weeks. While this foam includes known emollients, such as petrolatum and light mineral oil, it does not have the cosmetic disadvantages of a cream or ointment.7,8 The foam is a nongreasy, low-residue, stain-free, quick-drying, and fragrance-free vehicle that can be easily and gently applied to irritated skin.4,8
Because a product's vehicle is an important consideration in patient acceptance to topical therapy,9 this is the first clinical assessment of the safety, efficacy, and quality of life impact of treatment with clobetasol propionate 0.05% EF foam for chronic hand dermatitis.
This was an open-label, single-arm study conducted at a single center in the United States between November 14, 2008, and January 21, 2009 (NCT00828464).