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

NCT ID: NCT04214639

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-17
• Study Completion Date: 2021-01-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

IDP-126 Gel

Group Type: EXPERIMENTAL

IDP-126 Gel

Intervention Type: DRUG

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

IDP-126 Vehicle Gel

Group Type: PLACEBO_COMPARATOR

IDP-126 Vehicle Gel

Intervention Type: DRUG

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

Interventions

IDP-126 Gel

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

Intervention Type: DRUG

IDP-126 Vehicle Gel

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Bausch Health

Locations

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

Bausch Site 108

Pflugerville, Texas, United States

Bausch Site 101

Barrie, Ontario, Canada

Bausch Site 113

Waterloo, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 40377868 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38724841 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V01-126A-301

Identifier Type: -

Identifier Source: org_study_id