Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris

The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: IDP-126 Gel; Drug: IDP-126 Vehicle Gel; Drug: Epiduo® Forte Gel

Detailed Description

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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.

• Study Type: Interventional
• Enrollment (Actual): 686
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium
    • Bausch Site 136
  • Maldegem, Belgium
    • Bausch Site 140
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Bausch Site 138
  • Ontario
    • Markham, Ontario, Canada, L3P 1X3
      • Bausch Site 125
    • Oakville, Ontario, Canada, L6J 7W5
      • Bausch Site 141
    • Peterborough, Ontario, Canada, K91 5K2
      • Bausch Site 115
    • Waterloo, Ontario, Canada, N2J 1C4
      • Bausch Site 130
  • Quebec
    • Saint-Jérôme, Quebec, Canada, J7Z 7E2
      • Bausch Site 113
• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Bausch Site 134
    • Rogers, Arkansas, United States, 72758
      • Bausch Site 118
  • California
    • Fremont, California, United States, 94538
      • Bausch Site 110
    • Manhattan Beach, California, United States, 90266
      • Bausch Site 101
    • San Diego, California, United States, 92123
      • Bausch Site 106
    • San Diego, California, United States, 92123
      • Bausch Site 112
    • San Diego, California, United States, 92123
      • Bausch Site 128
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Bausch Site 105
    • Clearwater, Florida, United States, 33761
      • Bausch Site 126
    • North Miami Beach, Florida, United States, 33162
      • Bausch Site 135
    • Sanford, Florida, United States, 32771
      • Bausch Site 143
    • Tampa, Florida, United States, 33607
      • Bausch Site 102
    • West Palm Beach, Florida, United States, 33401
      • Bausch Site 104
    • West Palm Beach, Florida, United States, 33406
      • Bausch Site 122
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Bausch Site 124
  • Idaho
    • Boise, Idaho, United States, 83704
      • Bausch Site 127
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Bausch Site 129
  • Louisiana
    • Mandeville, Louisiana, United States, 70448
      • Bausch Site 139
    • Metairie, Louisiana, United States, 70006
      • Bausch Site 121
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Bausch Site 116
  • Massachusetts
    • Brighton, Massachusetts, United States, 21350
      • Bausch Site 103
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Bausch Site 120
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Bausch Site 108
  • New York
    • New York, New York, United States, 10022
      • Bausch Site 119
    • New York, New York, United States, 10075
      • Bausch Site 133
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Bausch Site 142
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Bausch Site 109
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Bausch Site 117
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Bausch Site 107
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Bausch Site 114
  • Texas
    • Austin, Texas, United States, 78759
      • Bausch Site 111
    • Houston, Texas, United States, 77098
      • Bausch Site 132
    • Pflugerville, Texas, United States, 78660
      • Bausch Site 123
  • Washington
    • Spokane, Washington, United States, 99202
      • Bausch Site 137

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female at least 12 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-126 Gel	Drug: IDP-126 Gel; Gel applied to face once daily in the evening.; Other Names: IDP-126
Placebo Comparator: IDP-126 Vehicle Gel	Drug: IDP-126 Vehicle Gel; Gel applied to face once daily in the evening.; Other Names: Vehicle
Active Comparator: Epiduo® Forte Gel	Drug: Epiduo® Forte Gel; Gel applied to face once daily in the evening.; Other Names: Epiduo® Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change from Baseline to Week 12 in lesion counts.		Baseline to Week 12
Percentage of subjects who achieve at least a two-grade reduction from baseline and are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score.	EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Varsha Bhatt, Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adapalene, Benzoyl Peroxide Drug Combination
• Other Study ID Numbers: V01-126A-202

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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