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

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04892706
Collaborator
(none)
686
42
3
14.7
16.3
1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: IDP-126 Gel
  • Drug: IDP-126 Vehicle Gel
  • Drug: Epiduo® Forte Gel
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
686 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 11, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Absolute change from Baseline to Week 12 in lesion counts. [Baseline to Week 12]

    2. 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. [Baseline to Week 12]

      EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bausch Site 134 Bryant Arkansas United States 72022
    2 Bausch Site 118 Rogers Arkansas United States 72758
    3 Bausch Site 110 Fremont California United States 94538
    4 Bausch Site 101 Manhattan Beach California United States 90266
    5 Bausch Site 106 San Diego California United States 92123
    6 Bausch Site 112 San Diego California United States 92123
    7 Bausch Site 128 San Diego California United States 92123
    8 Bausch Site 105 Boynton Beach Florida United States 33437
    9 Bausch Site 126 Clearwater Florida United States 33761
    10 Bausch Site 135 North Miami Beach Florida United States 33162
    11 Bausch Site 143 Sanford Florida United States 32771
    12 Bausch Site 102 Tampa Florida United States 33607
    13 Bausch Site 104 West Palm Beach Florida United States 33401
    14 Bausch Site 122 West Palm Beach Florida United States 33406
    15 Bausch Site 124 Newnan Georgia United States 30263
    16 Bausch Site 127 Boise Idaho United States 83704
    17 Bausch Site 129 Louisville Kentucky United States 40241
    18 Bausch Site 139 Mandeville Louisiana United States 70448
    19 Bausch Site 121 Metairie Louisiana United States 70006
    20 Bausch Site 116 Rockville Maryland United States 20850
    21 Bausch Site 103 Brighton Massachusetts United States 21350
    22 Bausch Site 120 New Brighton Minnesota United States 55112
    23 Bausch Site 108 Las Vegas Nevada United States 89148
    24 Bausch Site 119 New York New York United States 10022
    25 Bausch Site 133 New York New York United States 10075
    26 Bausch Site 142 High Point North Carolina United States 27262
    27 Bausch Site 109 Dublin Ohio United States 43016
    28 Bausch Site 117 Oklahoma City Oklahoma United States 73112
    29 Bausch Site 107 Gresham Oregon United States 97030
    30 Bausch Site 114 Nashville Tennessee United States 37215
    31 Bausch Site 111 Austin Texas United States 78759
    32 Bausch Site 132 Houston Texas United States 77098
    33 Bausch Site 123 Pflugerville Texas United States 78660
    34 Bausch Site 137 Spokane Washington United States 99202
    35 Bausch Site 136 Kortrijk Belgium
    36 Bausch Site 140 Maldegem Belgium
    37 Bausch Site 138 Winnipeg Manitoba Canada R3M 3Z4
    38 Bausch Site 125 Markham Ontario Canada L3P 1X3
    39 Bausch Site 141 Oakville Ontario Canada L6J 7W5
    40 Bausch Site 115 Peterborough Ontario Canada K91 5K2
    41 Bausch Site 130 Waterloo Ontario Canada N2J 1C4
    42 Bausch Site 113 Saint-Jérôme Quebec Canada J7Z 7E2

    Sponsors and Collaborators

    • Bausch Health Americas, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch Health Americas, Inc.
    ClinicalTrials.gov Identifier:
    NCT04892706
    Other Study ID Numbers:
    • V01-126A-202
    First Posted:
    May 19, 2021
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 15, 2022