Completed

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

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What is being tested

IDP-126 Gel

+ IDP-126 Vehicle Gel

Drug
Who is being recruted

Acne Vulgaris+2

+ Sebaceous Gland Diseases

+ Skin Diseases

Over 9 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorBausch Health Americas, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 27, 2020

Actual date on which the first participant was enrolled.

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 IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.

Official TitleA Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris
NCT04214652
Principal SponsorBausch Health Americas, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 9 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Acne VulgarisSebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform Eruptions

Criteria

6 inclusion criteria required to participate
Male or female at least 9 years of age and older.
Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
Subject must have an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4 (severe) at the baseline visit.
Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100.
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9 exclusion criteria prevent from participating
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
Subjects with more than 2 facial nodules.
Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Suspended

Bausch Site 205

Rogers, United StatesOpen Bausch Site 205 in Google Maps
Suspended

Bausch Site 201

Manhattan Beach, United States
Suspended

Bausch Site 207

West Palm Beach, United States
Suspended

Bausch Site 208

Boise, United States
Completed13 Study Centers