A Randomized, Double-Blind Phase 4 Study of the Efficacy and Safety of Ethanol-Free Clobetasol Propionate Foam, 0.05%, vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis
March 2013 | Volume 12 | Issue 3 | Original Article | 328 | Copyright © 2013
Leon H. Kircik MD,a-c William J. Eastman MD,d and Jennifer Gwazdauskas MBAe
aMount Sinai Medical Center, New York, NY bIndiana University School of Medicine, Indianapolis, IN cPhysicians Skin Care, PLLC, Louisville, KY dNorth American Medical Affairs (Stiefel, a GSK company), Research Triangle Park, NC eClinical Development (Stiefel, a GSK company), Research Triangle Park, NC
BACKGROUND: Chronic hand dermatitis may have a significant detrimental effect on daily home-related and work-related activities, and quality of life (QOL). Clobetasol propionate foam, 0.05%, is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older.
OBJECTIVES: To demonstrate superior efficacy, similar safety, and superior QOL outcomes in subjects with moderate to severe chronic hand dermatitis following treatment with clobetasol propionate foam, 0.05%, compared with vehicle foam.
METHODS: In this randomized, double-blind, vehicle-controlled, parallel-group, multicenter study (ClinicalTrials.gov identifier NCT01323673), subjects aged 12 years and older with moderate to severe chronic hand dermatitis and an Investigator's Static Global Assessment (ISGA) score of 3 or 4 at baseline were randomized 1:1 to receive clobetasol propionate foam, 0.05%, or vehicle foam, twice daily over 15 days. The primary end point was the proportion of subjects who achieved treatment success, defined as improvement from baseline of ≥2 ISGA grades for the target hand at day 15.
RESULTS: In total, 125 subjects were enrolled: 62 subjects were randomized to the clobetasol propionate foam group and 63 subjects were randomized to the vehicle foam group. The proportion of subjects with treatment success at day 15 did not differ significantly between treatment groups. Adverse events (AEs) were reported in 18% of subjects in the clobetasol propionate foam group and 8% of subjects in the vehicle foam group. No serious AEs, AEs resulting in discontinuation of study product, or severe AEs were reported in the clobetasol propionate foam group.
CONCLUSIONS: Clobetasol propionate foam, 0.05%, was not significantly more efficacious than vehicle foam at improving chronic hand dermatitis on investigator-assessed end points. Emollient properties of the study product vehicle may be a confounder in the study.
J Drugs Dermatol. 2013;12(3):328-334.
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Hand dermatitis, most commonly manifesting as eczema, broadly encompasses any type of inflammation involving the skin of the hands, and is commonly characterized by pruritus, erythema, scaling, and fissuring.1 The condition has an estimated 1-year prevalence of 10% in the general population,2 and 5% to 7% of patients with hand dermatitis have chronic or severe symptoms, while 2% to 4% are refractory to treatment.1 Both genetic and environmental factors are important in the etiology of hand dermatitis, with risk factors including the use of latex gloves, chemical exposure, frequent hand washing, history of childhood eczema, and female gender.2-5 Symptoms, which vary according to the type of hand dermatitis, may have a significant detrimental effect on daily home-related and work-related activities, and also on patient quality of life (QOL).6
Treatment for hand dermatitis must address acute symptoms, often including intense pruritus and the presence of vesicles that may weep and crust, and chronic symptoms, including erythema and scaling, leading to skin fissuring and lichenification.3 Group 1 (superpotent) topical corticosteroids are commonly used for the treatment of chronic hand dermatitis3,7; however, long-term use of topical corticosteroids may result in atrophy,