NCT03168321

A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-123 Lotion and IDP-123 Vehicle Lotion in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 813 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 9 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.

Detailed description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle Lotion. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	IDP-123 Lotion	Tazarotene 0.045% Lotion
DRUG	IDP-123 Vehicle Lotion	Vehicle Lotion

Timeline

• Start date: 2017-06-29
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2017-05-30
• Last updated: 2021-04-01
• Results posted: 2021-04-01

Locations

45 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study