A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: IDP-126 Vehicle Gel; Drug: IDP-126 Gel; Drug: IDP-126 Component A; Drug: IDP-126 Component B; Drug: IDP-126 Component C

• Registration Number: NCT03170388
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Detailed Description

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Study Timeline

• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Study Start: 2017-10-05
• Primary Completion: 2019-04-23
• Study Completion: 2019-04-23
• Disposition First Submitted: 2019-10-21
• Results First Submitted: 2021-09-17
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-13
• Disposition First Submitted QC: 2021-10-13
• Last Update Submitted: 2021-10-13
• Results First Posted: 2021-11-10
• Disposition First Posted: 2021-11-10
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 741

Inclusion Criteria

1. Male or female at least 9 years of age and older.
2. 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).
3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
6. Subjects with 2 or fewer facial nodules

Exclusion Criteria

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
2. 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.
3. 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.
4. Subjects with a facial beard or mustache that could interfere with the study assessments.
5. Subjects with more than 2 facial nodules.
6. Evidence or history of cosmetic-related acne.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-126 Vehicle Gel	IDP-126 Vehicle Gel	Vehicle Gel
IDP-126 Gel	IDP-126 Gel	Gel
IDP-126 Component A	IDP-126 Component A	Component A
IDP-126 Component B	IDP-126 Component B	Component B
IDP-126 Component C	IDP-126 Component C	Component C

Primary Outcome Measures

Name	Time	Method
Non-inflammatory Lesion Counts	Baseline to Week 12	Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts
Percentage of Participants With Success on the Evaluator's Global Severity Score	Baseline to Week 12	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.
Inflammatory Lesion Counts	Baseline to Week 12	Absolute change from Baseline to Week 12 in mean inflammatory lesion counts

Secondary Outcome Measures

Name	Time	Method
Inflammatory Lesion Count Changes at Week 2, 4, and 8	Baseline to Week 2, 4, 8	Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8	Baseline to Week 2, 4, 8	Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8	Baseline to Week 2, 4, 8	Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8	Baseline to Week 2, 4, 8	Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8	Baseline to Week 2, 4, and 8	Success was defined as at least a two grade reduction and clear or almost clear at the visit. 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.
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8	Baseline to Week 2, 4, and 8	Two grade success was defined as at least a two grade reduction. 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.

Trial Locations

Locations (34)

Valeant Site 22; 🇺🇸 Detroit, Michigan, United States

Valeant Site 31; 🇺🇸 Nashville, Tennessee, United States

Valeant Site 26; 🇺🇸 New York, New York, United States

Valeant Site 28; 🇺🇸 Gresham, Oregon, United States

Valeant Site 32; 🇺🇸 Austin, Texas, United States

Valeant Site 05; 🇨🇦 Barrie, Ontario, Canada

Valeant Site 06; 🇨🇦 Oakville, Ontario, Canada

valeant Site 21; 🇺🇸 Glenn Dale, Maryland, United States

Valeant Site 07; 🇺🇸 Fremont, California, United States

Valeant Site 09; 🇺🇸 Denver, Colorado, United States

Valeant Site 14; 🇺🇸 Snellville, Georgia, United States

Valeant Site 23; 🇺🇸 High Point, North Carolina, United States

Valeant Site 20; 🇺🇸 Needham, Massachusetts, United States

Valeant Site 12; 🇺🇸 Sanford, Florida, United States

Valeant Site 25; 🇺🇸 Albuquerque, New Mexico, United States

Valeant Site 17; 🇺🇸 Overland Park, Kansas, United States

Valeant Site 27; 🇺🇸 New York, New York, United States

Valeant Site 33; 🇺🇸 Pflugerville, Texas, United States

Valeant Site 35; 🇺🇸 Norfolk, Virginia, United States

Valeant Site 04; 🇨🇦 Peterborough, Ontario, Canada

Valeant Site 03; 🇨🇦 Waterloo, Ontario, Canada

Valeant Site 11; 🇺🇸 Boynton Beach, Florida, United States

Valeant Site 02; 🇺🇸 Hot Springs, Arkansas, United States

Valeant Site 08; 🇺🇸 Sacramento, California, United States

Valeant Site 13; 🇺🇸 North Miami Beach, Florida, United States

Valeant Site 15; 🇺🇸 Marietta, Georgia, United States

Valeant Site 16; 🇺🇸 Boise, Idaho, United States

Valeant Site 10; 🇺🇸 West Palm Beach, Florida, United States

Valeant Site 18; 🇺🇸 Louisville, Kentucky, United States

Valeant Site 19; 🇺🇸 Louisville, Kentucky, United States

Valeant Site 24; 🇺🇸 Morristown, New Jersey, United States

Valeant Site 30; 🇺🇸 Johnston, Rhode Island, United States

valeant Site 34; 🇺🇸 San Antonio, Texas, United States

Valeant Site 01; 🇨🇦 Winnipeg, Manitoba, Canada