Conditions: Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 267
Healthy volunteers: no

Brief summary:
This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

Detailed description:
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.

Arms:
arm 1: DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days. arm 2: Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Interventions: intervention 1: DFD06 Cream intervention 2: Vehicle Cream
Intervention descriptions: intervention 1: Twice daily topical application for 14 days. intervention 2: Twice daily topical application for 14 days.

Protocol document: