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

NCT03170388 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: V01-126A-201
• Study Type: interventional
• Target: 741
• Locations: 2 countries
• Sites: 34

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Inflammatory Lesion Counts

  Absolute change from Baseline to Week 12 in mean inflammatory lesion counts

  Baseline to Week 12

• Non-inflammatory Lesion Counts

  Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts

  Baseline to Week 12

• 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.

  Baseline to Week 12

Secondary Outcomes (6)

• Inflammatory Lesion Count Changes at Week 2, 4, and 8

  Baseline to Week 2, 4, 8

• Non-inflammatory Lesion Count Changes at Week 2, 4, and 8

  Baseline to Week 2, 4, 8

• Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8

  Baseline to Week 2, 4, 8

• Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8

  Baseline to Week 2, 4, 8

• 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

Study Arms (5)

IDP-126 Gel

EXPERIMENTAL

Gel

Drug: IDP-126 Gel

IDP-126 Component A

ACTIVE COMPARATOR

Component A

Drug: IDP-126 Component A

IDP-126 Component B

ACTIVE COMPARATOR

Component B

Drug: IDP-126 Component B

IDP-126 Component C

ACTIVE COMPARATOR

Component C

Drug: IDP-126 Component C

IDP-126 Vehicle Gel

PLACEBO COMPARATOR

Vehicle Gel

Drug: IDP-126 Vehicle Gel

Interventions

IDP-126 Gel DRUG

Gel

IDP-126 Gel

IDP-126 Component A DRUG

Component A

IDP-126 Component A

IDP-126 Component B DRUG

Component B

IDP-126 Component B

IDP-126 Component C DRUG

Component C

IDP-126 Component C

IDP-126 Vehicle Gel DRUG

Vehicle Gel

IDP-126 Vehicle Gel

Eligibility Criteria

• Age: 9 Years - 99 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 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 20, but no more than 100.
• Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
• Subjects with 2 or fewer facial nodules

You may not qualify if:

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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (34)

Valeant Site 02

Hot Springs, Arkansas, 71913, United States

Location

Valeant Site 07

Fremont, California, 94538, United States

Location

Valeant Site 08

Sacramento, California, 95819, United States

Location

Valeant Site 09

Denver, Colorado, 80220, United States

Location

Valeant Site 11

Boynton Beach, Florida, 33437, United States

Location

Valeant Site 13

North Miami Beach, Florida, 33162, United States

Location

Valeant Site 12

Sanford, Florida, 32771, United States

Location

Valeant Site 10

West Palm Beach, Florida, 33401, United States

Location

Valeant Site 15

Marietta, Georgia, 30060, United States

Location

Valeant Site 14

Snellville, Georgia, 30078, United States

Location

Valeant Site 16

Boise, Idaho, 83704, United States

Location

Valeant Site 17

Overland Park, Kansas, 66215, United States

Location

Valeant Site 18

Louisville, Kentucky, 40217, United States

Location

Valeant Site 19

Louisville, Kentucky, 40241, United States

Location

valeant Site 21

Glenn Dale, Maryland, 20769, United States

Location

Valeant Site 20

Needham, Massachusetts, 02492, United States

Location

Valeant Site 22

Detroit, Michigan, 48202, United States

Location

Valeant Site 24

Morristown, New Jersey, 07960, United States

Location

Valeant Site 25

Albuquerque, New Mexico, 87106, United States

Location

Valeant Site 27

New York, New York, 10022, United States

Location

Valeant Site 26

New York, New York, 10075, United States

Location

Valeant Site 23

High Point, North Carolina, 27262, United States

Location

Valeant Site 28

Gresham, Oregon, 97030, United States

Location

Valeant Site 30

Johnston, Rhode Island, 02919, United States

Location

Valeant Site 31

Nashville, Tennessee, 37215, United States

Location

Valeant Site 32

Austin, Texas, 78759, United States

Location

Valeant Site 33

Pflugerville, Texas, 78660, United States

Location

valeant Site 34

San Antonio, Texas, 78213, United States

Location

Valeant Site 35

Norfolk, Virginia, 23502, United States

Location

Valeant Site 01

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Valeant Site 05

Barrie, Ontario, L4M7G1, Canada

Location

Valeant Site 06

Oakville, Ontario, L6J7W5, Canada

Location

Valeant Site 04

Peterborough, Ontario, K9J5K2, Canada

Location

Valeant Site 03

Waterloo, Ontario, N2J1C4, 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

• Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.

  PMID: 34674160 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

aloncaric@bauschhealth.com

5102595284

Study Officials

• Anya Loncaric

  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, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: October 5, 2017
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (5); US (29)