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

NCT04892706 | Completed Phase 2 Results FDA Drug

• 1 other identifier: V01-126A-202
• Study Type: interventional
• Target: 686
• Locations: 3 countries
• Sites: 42

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Absolute Change From Baseline to Week 12 in Lesion Counts.

  Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.

  Baseline to Week 12

• Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.

  The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

  Baseline to Week 12

Study Arms (3)

IDP-126 Gel

EXPERIMENTAL

IDP-126 Gel (clindamycin phosphate 1.2%, BPO 3.1%, and adapalene 0.15%), applied topically to the face once daily for 12 weeks

Drug: IDP-126 Gel

IDP-126 Vehicle Gel

PLACEBO COMPARATOR

IDP-126 Vehicle Gel applied once daily for 12 weeks

Drug: IDP-126 Vehicle Gel

Epiduo® Forte Gel

ACTIVE COMPARATOR

Epiduo® Forte Gel (adapalene 0.3%/ 2.5% BPO) applied once daily for 12 weeks

Drug: Epiduo® Forte Gel

Interventions

IDP-126 Gel DRUG

Gel applied to face once daily in the evening.

Also known as: IDP-126

IDP-126 Gel

IDP-126 Vehicle Gel DRUG

Gel applied to face once daily in the evening.

Also known as: Vehicle

IDP-126 Vehicle Gel

Epiduo® Forte Gel DRUG

Gel applied to face once daily in the evening.

Also known as: Epiduo® Forte

Epiduo® Forte Gel

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (42)

Bausch Site 134

Bryant, Arkansas, 72022, United States

Location

Bausch Site 118

Rogers, Arkansas, 72758, United States

Location

Bausch Site 110

Fremont, California, 94538, United States

Location

Bausch Site 101

Manhattan Beach, California, 90266, United States

Location

Bausch Site 106

San Diego, California, 92123, United States

Location

Bausch Site 112

San Diego, California, 92123, United States

Location

Bausch Site 128

San Diego, California, 92123, United States

Location

Bausch Site 105

Boynton Beach, Florida, 33437, United States

Location

Bausch Site 126

Clearwater, Florida, 33761, United States

Location

Bausch Site 135

North Miami Beach, Florida, 33162, United States

Location

Bausch Site 143

Sanford, Florida, 32771, United States

Location

Bausch Site 102

Tampa, Florida, 33607, United States

Location

Bausch Site 104

West Palm Beach, Florida, 33401, United States

Location

Bausch Site 122

West Palm Beach, Florida, 33406, United States

Location

Bausch Site 124

Newnan, Georgia, 30263, United States

Location

Bausch Site 127

Boise, Idaho, 83704, United States

Location

Bausch Site 129

Louisville, Kentucky, 40241, United States

Location

Bausch Site 139

Mandeville, Louisiana, 70448, United States

Location

Bausch Site 121

Metairie, Louisiana, 70006, United States

Location

Bausch Site 116

Rockville, Maryland, 20850, United States

Location

Bausch Site 103

Brighton, Massachusetts, 21350, United States

Location

Bausch Site 120

New Brighton, Minnesota, 55112, United States

Location

Bausch Site 108

Las Vegas, Nevada, 89148, United States

Location

Bausch Site 119

New York, New York, 10022, United States

Location

Bausch Site 133

New York, New York, 10075, United States

Location

Bausch Site 142

High Point, North Carolina, 27262, United States

Location

Bausch Site 109

Dublin, Ohio, 43016, United States

Location

Bausch Site 117

Oklahoma City, Oklahoma, 73112, United States

Location

Bausch Site 107

Gresham, Oregon, 97030, United States

Location

Bausch Site 114

Nashville, Tennessee, 37215, United States

Location

Bausch Site 111

Austin, Texas, 78759, United States

Location

Bausch Site 132

Houston, Texas, 77098, United States

Location

Bausch Site 123

Pflugerville, Texas, 78660, United States

Location

Bausch Site 137

Spokane, Washington, 99202, United States

Location

Bausch Site 136

Kortrijk, Belgium

Location

Bausch Site 140

Maldegem, Belgium

Location

Bausch Site 138

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Bausch Site 125

Markham, Ontario, L3P 1X3, Canada

Location

Bausch Site 141

Oakville, Ontario, L6J 7W5, Canada

Location

Bausch Site 115

Peterborough, Ontario, K91 5K2, Canada

Location

Bausch Site 130

Waterloo, Ontario, N2J 1C4, Canada

Location

Bausch Site 113

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Related Publications (1)

• Gold M, Lain T, Harper JC, Baldwin H, Guenin E, Stein Gold L. Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity. Dermatol Ther (Heidelb). 2025 Jul;15(7):1867-1882. doi: 10.1007/s13555-025-01440-z. Epub 2025 May 16.

  PMID: 40377868 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health Americas, Inc

alison.magnotti-nagel@bauschhealth.com

908-541-8664

Study Officials

• Varsha Bhatt

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: June 11, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 30, 2025
• Results First Posted: October 30, 2025

Record last verified: 2025-10

Locations

US (34); BE (2); CA (6)