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Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

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

NCT04214639•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

9 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150.
•Subjects with 2 or fewer facial nodules.

Exclusion Criteria

•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.
•Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study.
•Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area.
•Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area.
•Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications.
•Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Locations (13)

Bausch Site 110

Bryant, Arkansas, United States

Bausch Site 104

Fremont, California, United States

Bausch Site 109

Denver, Colorado, United States

Bausch Site 102

Boynton Beach, Florida, United States

Bausch Site 111

North Miami Beach, Florida, United States

Bausch Site 106

Sanford, Florida, United States

Bausch Site 103

Las Vegas, Nevada, United States

Bausch Site 114

New York, New York, United States

Bausch Site 105

High Point, North Carolina, United States

Bausch Site 107

Nashville, Tennessee, United States

Key Dates

Start Date

January 17, 2020

Primary Completion Date

January 18, 2021

Completion Date

January 18, 2021

Last Updated

February 1, 2024

Enrollment

183

ACTUAL participants

Conditions

Acne Vulgaris

Interventions

IDP-126 Gel

DRUG

IDP-126 Vehicle Gel

DRUG

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

NCT07205107

Acne Vulgaris

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RECRUITINGPHASE1/PHASE2

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795

Acne Vulgaris

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RECRUITINGNA

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Inclusion Criteria

Exclusion Criteria

Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Triple Combination Gel in Canadian Patients With Acne Vulgaris

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Profiles Analysis of Genome Wide Association Study (GWAS) in Acne Vulgaris in Indonesia.

Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris

Auricular Acupressure Combined With Adapalene for the Treatment of Acne Vulgaris