Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05%
March 2016 | Volume 15 | Issue 3 | Original Article | 334 | Copyright © March 2016
Linda Stein Gold MD,a J. Mark Jackson MD,b Melissa L.F. Knuckles MD,c,d and Jonathan S. Weiss MDe
aHenry Ford Medical Center, Detroit, MI
bUniversity of Louisville, Division of Dermatology, Louisville, KY
cUniversity of Louisville, Louisville, KY
dPikeville School of Osteopathic Medicine, Pikeville, KY
eGwinnett Dermatology, Snellville, GA
OBJECTIVE: To compare the efficacy and safety of DFD-01 to its vehicle for the treatment of moderate plaque psoriasis over 4 weeks.
METHODS: Two Phase 3 trials enrolled adults with moderate psoriasis (Investigator Global Assessment [IGA]=3; 10–20% body surface area [BSA]) and randomized them 2:1 to DFD-01 or Vehicle. Products were applied twice daily to affected areas for 28 days. Treatment success was defined as an IGA=0 or 1 and ≥2-grade improvement from baseline. Primary endpoint was the proportion of subjects achieving treatment success at day 15.
RESULTS: Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; 87 Vehicle) and Study 2 (182 DFD-01; 95 Vehicle). Mean BSA was 13–14%. Treatment success was achieved in significantly more subjects using DFD-01 than Vehicle at day 15 in both Study 1 (P<0.001) and Study 2 (P=0.002), and at day 29 (both studies P<0.001). Treatment success with DFD-01 was significant at day 8 in Study 1 (P=0.003) but not in Study 2 (P=0.156). Erythema, scaling, and plaque elevation scores of target lesions were significantly reduced as early as day 4 with DFD-01. Adverse events were similar between groups, with no increase between 2 and 4 weeks.
CONCLUSION: These studies demonstrate DFD-01’s excellent efficacy and safety for the treatment of extensive psoriasis (10–20% BSA). DFD-01 achieved treatment success in significantly more subjects than Vehicle after 2 and 4 weeks of treatment, and showed early onset of action with improved signs of erythema, scaling and elevation of target lesions after 4 days of treatment. This medium potency formulation provides a safe and effective choice for topical steroid treatment of psoriasis.
J Drugs Dermatol. 2016;15(3):334-342.