Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Last updated: December 16, 2019
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Acne

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT02932306
V01-121A-301
  • Ages > 9
  • All Genders

Study Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female at least 9 years of age and older.

  • Written and verbal informed consent must be obtained. Participants less than age ofconsent must sign an assent for the study and a parent or a legal guardian must signthe informed consent (if participant reaches age of consent during the study theyshould be re-consented at the next study visit).

  • Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment atthe screening and baseline visit

Exclusion

Key Exclusion Criteria:

  • Use of an investigational drug or device within 30 days of enrollment or participationin a research study concurrent with this study.

  • Any dermatological conditions on the face that could interfere with clinicalevaluations such as acne conglobata, acne fulminans, secondary acne, perioraldermatitis, clinically significant rosacea, gram-negative folliculitis.

  • Any underlying disease(s) or some other dermatological condition of the face thatrequires the use of interfering topical or systemic therapy or makes evaluations andlesion count inconclusive.

  • Participants with a facial beard or mustache that could interfere with the studyassessments.

Study Design

Total Participants: 820
Study Start date:
November 03, 2015
Estimated Completion Date:
February 22, 2017

Connect with a study center

  • Valeant Site 36

    Guntersville, Alabama 35976
    United States

    Site Not Available

  • Valeant Site 14

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Valeant Site 28

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Valeant Site 38

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Valeant Site 34

    Manhattan Beach, California 90266
    United States

    Site Not Available

  • Valeant Site 23

    Ocean Side, California 92056
    United States

    Site Not Available

  • Valeant Site 23

    Oceanside, California 92056
    United States

    Site Not Available

  • Valeant Site 35

    Ranch Cucamonga, California 91730
    United States

    Site Not Available

  • Valeant Site 35

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Valeant Site 20

    San Diego, California 92123
    United States

    Site Not Available

  • Valeant Site 32

    Denver, Colorado 80220
    United States

    Site Not Available

  • Valeant Site 10

    Shelton, Connecticut 06484
    United States

    Site Not Available

  • Valeant Site 02

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Valeant Site 15

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Valeant Site 37

    Miami, Florida 33142
    United States

    Site Not Available

  • Valeant Site 39

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • Valeant Site 39

    Pembroke Pines`, Florida 33028
    United States

    Site Not Available

  • Valeant Site 01

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Valeant Site 19

    Boise, Idaho 83704
    United States

    Site Not Available

  • Valeant Site 04

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Valeant Site 27

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Valeant 12

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Valeant Site 09

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Valeant Site 16

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Valeant Site 33

    Needham, Massachusetts 02492
    United States

    Site Not Available

  • Valeant Site 11

    Warren, Michigan 48088
    United States

    Site Not Available

  • Valeant Site 08

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Valeant Site 25

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Valeant Site 13

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Valeant Site 03

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Valeant Site 26

    New York, New York 10022
    United States

    Site Not Available

  • Valeant Site 31

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Valeant 05

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Valeant Site 22

    Fort Washington, Pennsylvania 19034
    United States

    Site Not Available

  • Valeant Site 24

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Valeant Site 06

    Dallas, Texas 75231
    United States

    Site Not Available

  • Valeant Site 30

    Houston, Texas 77004
    United States

    Site Not Available

  • Valeant Site 17

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Valeant Site 07

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Valeant 18

    Webster, Texas 77598
    United States

    Site Not Available

  • Valeant Site 29

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • Valeant Site 21

    Norfolk, Virginia 23502
    United States

    Site Not Available

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