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

NCT04214652 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V01-126A-302
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 13

Brief 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

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

  12 weeks

• Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts

  12 weeks

• Percentage of Participants With Success on the Evaluator's Global Severity Score

  Success was defined as at least a two grade reduction and clear or almost clear at Week 12. 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.

  12 weeks

Secondary Outcomes (3)

• Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12

  Baseline to Week 4, 8, 12

• Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12

  Baseline to Week 4, 8, 12

• Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12

  12 weeks

Study Arms (2)

IDP-126 Gel

EXPERIMENTAL

Drug: IDP-126 Gel

IDP-126 Vehicle Gel

PLACEBO COMPARATOR

Drug: IDP-126 Vehicle Gel

Interventions

IDP-126 Gel DRUG

IDP-126 Gel applied topically to the face once daily for 12 weeks.

IDP-126 Gel

IDP-126 Vehicle Gel DRUG

IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.

IDP-126 Vehicle Gel

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 (13)

Bausch Site 205

Rogers, Arkansas, 72758, United States

Location

Bausch Site 201

Manhattan Beach, California, 90266, United States

Location

Bausch Site 207

West Palm Beach, Florida, 33406, United States

Location

Bausch Site 208

Boise, Idaho, 83704, United States

Location

Bausch Site 209

Louisville, Kentucky, 40241, United States

Location

Bausch Site 202

Brighton, Massachusetts, 21350, United States

Location

Bausch Site 212

Detroit, Michigan, 48202, United States

Location

Bausch Site 206

New York, New York, 10022, United States

Location

Bausch Site 203

Gresham, Oregon, 97030, United States

Location

Bausch Site 204

Johnston, Rhode Island, 29190, United States

Location

Bausch Site 213

Winnipeg, MN, R3M 3Z4, Canada

Location

Bausch Site 210

Oakville, Ontario, L6J 7W5, Canada

Location

Bausch Site 211

Peterborough, Ontario, K9J 5K2, Canada

Location

Related Publications (2)

• 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

• Kircik LH, Stein Gold L, Gold M, Weiss JS, Harper JC, Del Rosso JQ, Bunick CG, Bhatia N, Tanghetti EA, Eichenfield LF, Baldwin H, Draelos ZD, Callender VD, Han G, Gooderham MJ, Sadick N, Lupo MP, Lain ET, Werschler WP. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis. Dermatol Ther (Heidelb). 2024 May;14(5):1211-1227. doi: 10.1007/s13555-024-01155-7. Epub 2024 May 9.

  PMID: 38724841 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

Varsha.Bhatt@bauschhealth.com

7072851528

Study Officials

• Anya Loncaric

  Bausch Health

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: December 30, 2019
• First Posted: January 2, 2020
• Study Start: January 27, 2020
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Locations

CA (3); US (10)