Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05.

Abstract

BACKGROUND:

A novel formulation of 0.05% betamethasone dipropionate in an emollient spray vehicle (DFD-01) was developed to deliver steroid to the skin layers most affected by psoriasis.

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.

• Authors: Linda Stein Gold, J Mark Jackson, Melissa L F Knuckles, Jonathan S Weiss
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 15 Issue 3 Pg. 334-42 (Mar 2016) ISSN: 1545-9616 [Print] United States
• PMID: 26954319 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Emollients
• Glucocorticoids
• Pharmaceutical Vehicles
• betamethasone-17,21-dipropionate
• Betamethasone

Topics

• Administration, Topical
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Betamethasone (administration & dosage, adverse effects, analogs & derivatives, chemistry)
• Body Surface Area
• Double-Blind Method
• Emollients (administration & dosage, chemistry)
• Female
• Glucocorticoids (administration & dosage, adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Pharmaceutical Vehicles (administration & dosage, chemistry)
• Psoriasis (drug therapy)
• Skin (drug effects)
• Treatment Outcome
• Young Adult