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New acne gel shows promise in Head-to-Head trial

NCT ID NCT04892706

Symptom relief Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tested a new acne gel called IDP-126 against a standard gel (Epiduo Forte) and a placebo gel in 686 people aged 12 and older with moderate to severe acne. Participants applied the gel once daily for 12 weeks. Researchers measured changes in acne lesion counts and overall skin clarity to see if the new gel works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IDP-126 gel (a combination acne treatment applied to the skin once daily)
What this could lead to
If it works, this could offer a new once-daily gel option for treating moderate to severe acne.
What could go wrong
This is a Phase 2 trial, so results are still early. The gel may not prove more effective than existing treatments, and side effects like skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

686 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female at least 12 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 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.

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acne vulgaris

Contacts and locations

Locations

  • Bausch Site 101

    Manhattan Beach, California, 90266, United States

  • Bausch Site 102

    Tampa, Florida, 33607, United States

  • Bausch Site 103

    Brighton, Massachusetts, 21350, United States

  • Bausch Site 104

    West Palm Beach, Florida, 33401, United States

  • Bausch Site 105

    Boynton Beach, Florida, 33437, United States

  • Bausch Site 106

    San Diego, California, 92123, United States

  • Bausch Site 107

    Gresham, Oregon, 97030, United States

  • Bausch Site 108

    Las Vegas, Nevada, 89148, United States

  • Bausch Site 109

    Dublin, Ohio, 43016, United States

  • Bausch Site 110

    Fremont, California, 94538, United States

  • Bausch Site 111

    Austin, Texas, 78759, United States

  • Bausch Site 112

    San Diego, California, 92123, United States

  • Bausch Site 113

    Saint-Jérôme, Quebec, J7Z 7E2, Canada

  • Bausch Site 114

    Nashville, Tennessee, 37215, United States

  • Bausch Site 115

    Peterborough, Ontario, K91 5K2, Canada

  • Bausch Site 116

    Rockville, Maryland, 20850, United States

  • Bausch Site 117

    Oklahoma City, Oklahoma, 73112, United States

  • Bausch Site 118

    Rogers, Arkansas, 72758, United States

  • Bausch Site 119

    New York, New York, 10022, United States

  • Bausch Site 120

    New Brighton, Minnesota, 55112, United States

  • Bausch Site 121

    Metairie, Louisiana, 70006, United States

  • Bausch Site 122

    West Palm Beach, Florida, 33406, United States

  • Bausch Site 123

    Pflugerville, Texas, 78660, United States

  • Bausch Site 124

    Newnan, Georgia, 30263, United States

  • Bausch Site 125

    Markham, Ontario, L3P 1X3, Canada

  • Bausch Site 126

    Clearwater, Florida, 33761, United States

  • Bausch Site 127

    Boise, Idaho, 83704, United States

  • Bausch Site 128

    San Diego, California, 92123, United States

  • Bausch Site 129

    Louisville, Kentucky, 40241, United States

  • Bausch Site 130

    Waterloo, Ontario, N2J 1C4, Canada

  • Bausch Site 132

    Houston, Texas, 77098, United States

  • Bausch Site 133

    New York, New York, 10075, United States

  • Bausch Site 134

    Bryant, Arkansas, 72022, United States

  • Bausch Site 135

    North Miami Beach, Florida, 33162, United States

  • Bausch Site 136

    Kortrijk, Belgium

  • Bausch Site 137

    Spokane, Washington, 99202, United States

  • Bausch Site 138

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Bausch Site 139

    Mandeville, Louisiana, 70448, United States

  • Bausch Site 140

    Maldegem, Belgium

  • Bausch Site 141

    Oakville, Ontario, L6J 7W5, Canada

  • Bausch Site 142

    High Point, North Carolina, 27262, United States

  • Bausch Site 143

    Sanford, Florida, 32771, United States

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