A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% Halobetasol Propionate) to Ultravate® (Halobetasol Propionate) Cream, in the Treatment of Plaque Psoriasis

NCT02785185 Phase 2 COMPLETED Results posted

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	150
Start date	2016-06
Completion	2017-01

Conditions

• Psoriasis

Interventions

• IDP-122 Vehicle Lotion
• IDP-122 Vehicle Cream
• IDP-122 Lotion
• Ultravate Cream

Primary outcomes

• Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 2 — 2 weeks
  Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Week 2. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).

Countries

United States