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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: IDP-126 Gel; Drug: IDP-126 Component A; Drug: IDP-126 Component B; Drug: IDP-126 Component C; Drug: IDP-126 Vehicle Gel

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 Type: Interventional
• Enrollment (Actual): 741
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Valeant Site 01
  • Ontario
    • Barrie, Ontario, Canada, L4M7G1
      • Valeant Site 05
    • Oakville, Ontario, Canada, L6J7W5
      • Valeant Site 06
    • Peterborough, Ontario, Canada, K9J5K2
      • Valeant Site 04
    • Waterloo, Ontario, Canada, N2J1C4
      • Valeant Site 03
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Valeant Site 02
  • California
    • Fremont, California, United States, 94538
      • Valeant Site 07
    • Sacramento, California, United States, 95819
      • Valeant Site 08
  • Colorado
    • Denver, Colorado, United States, 80220
      • Valeant Site 09
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Valeant Site 11
    • North Miami Beach, Florida, United States, 33162
      • Valeant Site 13
    • Sanford, Florida, United States, 32771
      • Valeant Site 12
    • West Palm Beach, Florida, United States, 33401
      • Valeant Site 10
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Valeant Site 15
    • Snellville, Georgia, United States, 30078
      • Valeant Site 14
  • Idaho
    • Boise, Idaho, United States, 83704
      • Valeant Site 16
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Valeant Site 17
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Valeant Site 18
    • Louisville, Kentucky, United States, 40241
      • Valeant Site 19
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Valeant Site 21
  • Massachusetts
    • Needham, Massachusetts, United States, 02492
      • Valeant Site 20
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Valeant Site 22
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Valeant Site 24
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Valeant Site 25
  • New York
    • New York, New York, United States, 10022
      • Valeant Site 27
    • New York, New York, United States, 10075
      • Valeant Site 26
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Valeant Site 23
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Valeant Site 28
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Valeant Site 30
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Valeant Site 31
  • Texas
    • Austin, Texas, United States, 78759
      • Valeant Site 32
    • Pflugerville, Texas, United States, 78660
      • Valeant Site 33
    • San Antonio, Texas, United States, 78213
      • Valeant Site 34
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Valeant Site 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-126 Gel; Gel	Drug: IDP-126 Gel; Gel
Active Comparator: IDP-126 Component A; Component A	Drug: IDP-126 Component A; Component A
Active Comparator: IDP-126 Component B; Component B	Drug: IDP-126 Component B; Component B
Active Comparator: IDP-126 Component C; Component C	Drug: IDP-126 Component C; Component C
Placebo Comparator: IDP-126 Vehicle Gel; Vehicle Gel	Drug: IDP-126 Vehicle Gel; Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Lesion Count Changes at Week 2, 4, and 8	Absolute change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts	Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Changes at Week 2, 4, and 8	Absolute change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts	Baseline to Week 2, 4, 8
Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8	Percentage change from Baseline to Week 2, 4, and 8 in mean inflammatory lesion counts	Baseline to Week 2, 4, 8
Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8	Percentage change from Baseline to Week 2, 4, and 8 in mean non-inflammatory lesion counts	Baseline to Week 2, 4, 8
Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 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.	Baseline to Week 2, 4, and 8
Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 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.	Baseline to Week 2, 4, and 8

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: V01-126A-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No