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

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: IDP-126 Gel; Drug: IDP-126 Vehicle Gel

• Registration Number: NCT04214639
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-01-17
• Primary Completion: 2021-01-18
• Study Completion: 2021-01-18
• Disposition First Submitted: 2022-01-14
• Disposition First Submitted QC: 2022-01-18
• Disposition First Posted: 2022-01-20
• Status Verified: 2024-01
• Results First Submitted: 2024-01-09
• Results First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Results First Posted: 2024-02-01
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-126 Gel	IDP-126 Gel	-
IDP-126 Vehicle Gel	IDP-126 Vehicle Gel	-

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	12 weeks
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts	12 weeks
Percentage of Participants With Success on the Evaluator's Global Severity Score	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	12 weeks	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.
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

Trial Locations

Locations (13)

Bausch Site 106; 🇺🇸 Sanford, Florida, United States

Bausch Site 110; 🇺🇸 Bryant, Arkansas, United States

Bausch Site 102; 🇺🇸 Boynton Beach, Florida, United States

Bausch Site 104; 🇺🇸 Fremont, California, United States

Bausch Site 109; 🇺🇸 Denver, Colorado, United States

Bausch Site 111; 🇺🇸 North Miami Beach, 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