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Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03003247
Collaborator
(none)
364
Enrollment
24
Locations
4
Arms
11
Actual Duration (Months)
15.2
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Condition or Disease Intervention/Treatment Phase
  • Drug: IDP-120 Gel
  • Drug: IDP 120 Component A Gel
  • Drug: IDP 120 Component B Gel
  • Drug: IDP 120 Vehicle Gel
 Phase 2

Detailed Description

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Study Design

Study Type:
Interventional
Actual Enrollment :
364 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Aug 31, 2016
Actual Study Completion Date :
Sep 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: IDP-120 Gel

IDP-120 Gel is a combination treatment

Drug: IDP-120 Gel
IDP-120 Gel is a combination product
Other Names:
  • Component A + B

    		•
    Active Comparator: IDP-120 Component A Gel

    IDP-120 Monad Gel of Component A

    Drug: IDP 120 Component A Gel
    Monad of Component A
    Other Names:
  • Component A

    		•
    Active Comparator: IDP-120 Component B Gel

    IDP-120 Monad Gel of Component B

    Drug: IDP 120 Component B Gel
    Monad of Component B
    Other Names:
  • Component B

    		•
    Placebo Comparator: IDP-120 Vehicle Gel

    IDP-120 Vehicle Gel

    Drug: IDP 120 Vehicle Gel
    Vehicle
    Other Names:
  • Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score. [12 Weeks]

      Percent 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    • 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)

    • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.

    • Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.

    • If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.

    Key Exclusion Criteria:

    • 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, gramnegative folliculitis.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Valeant Site 15 Encino California United States 91316
    2 Valeant Site 13 Lake Mary Florida United States 32746
    3 Valeant Site 16 Miami Florida United States 33101
    4 Valeant Site 14 Tampa Florida United States 33601
    5 Valeant Site 02 West Palm Beach Florida United States 33401
    6 Valeant Site 21 Atlanta Georgia United States 30302
    7 Valeant Site 23 South Bend Indiana United States 46601
    8 Valeant Site 09 Detroit Michigan United States 48204
    9 Valeant Site 24 Minneapolis Minnesota United States 55401
    10 Valeant Site 11 Saint Joseph Missouri United States 64502
    11 Valreant Site 05 New York New York United States 10001
    12 Valeant Site 06 New York New York United States 10002
    13 Valeant Site 01 Chapel Hill North Carolina United States 27517
    14 Valeant Site 17 High Point North Carolina United States 27268
    15 Valeant Site 22 Columbus Ohio United States 43085
    16 Valeant Site 04 Knoxville Tennessee United States 37901
    17 Valeant Site 07 Austin Texas United States 73301
    18 Valeant Site 12 Austin Texas United States 78701
    19 Valeant Site 18 San Antonio Texas United States 78204
    20 Valeant Site 25 Spokane Washington United States 99202
    21 Valeant Site 10 Winnepeg Manitoba Canada R2C 0A1
    22 Valeant Site 03 Markham Ontario Canada L3P 0A1
    23 Valeant Site 08 Waterloo Ontario Canada N2J 1L9
    24 Valeant Site 20 Windsor Ontario Canada N9A 2S6

    Sponsors and Collaborators

    • Bausch Health Americas, Inc.

    Investigators

    • Study Director: Anya Loncaric, Valeant Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch Health Americas, Inc.
    ClinicalTrials.gov Identifier:
    NCT03003247
    Other Study ID Numbers:
    • V01-120A-201
    First Posted:
    Dec 26, 2016
    Last Update Posted:
    Dec 18, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Dec 18, 2017