NCT04892706

Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 686 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.

Detailed description

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score \[EGSS\] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	IDP-126 Gel	Gel applied to face once daily in the evening.
DRUG	IDP-126 Vehicle Gel	Gel applied to face once daily in the evening.
DRUG	Epiduo® Forte Gel	Gel applied to face once daily in the evening.

Timeline

• Start date: 2021-06-11
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2021-05-19
• Last updated: 2025-10-30
• Results posted: 2025-10-30

Locations

42 sites across 3 countries: United States, Belgium, Canada

Regulatory

• FDA-regulated drug study