NCT02514577

Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-122 in the Treatment of Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment \[IGA\] score of 3 or 4).

Detailed description

This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	IDP-122 Lotion	Topical lotion
DRUG	IDP-122 Vehicle Lotion	Topical lotion. No active ingredient.

Timeline

• Start date: 2015-11-07
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-08-03
• Last updated: 2020-01-27
• Results posted: 2020-01-27

Locations

15 sites across 1 country: United States