NCT03664739

Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of IDP-120 Gel and IDP-120 Vehicle Gel in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Accepted

Summary

study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel

Detailed description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. 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-120 Gel	IDP-120 Gel, once-daily application
DRUG	IDp-120 Vehicle Gel	IDP-120 Vehicle Gel, once-daily application

Timeline

• Start date: 2018-12-05
• Primary completion: 2020-03-23
• Completion: 2020-03-23
• First posted: 2018-09-10
• Last updated: 2023-03-29
• Results posted: 2023-03-29

Locations

30 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study