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Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04214652
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
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 IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-126 Gel Drug: IDP-126 Vehicle Gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, 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
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-126 Gel Drug: IDP-126 Gel
IDP-126 Gel applied topically to the face once daily for 12 weeks.

Placebo Comparator: IDP-126 Vehicle Gel Drug: IDP-126 Vehicle Gel
IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.




Primary Outcome Measures :
  1. Absolute change from Baseline to Week 12 in inflammatory lesion counts [ Time Frame: 12 weeks ]
  2. Absolute change from Baseline to Week 12 in non-inflammatory lesion counts [ Time Frame: 12 weeks ]
  3. 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) [ Time Frame: 12 weeks ]
    EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  • Subject must have an Evaluator's Global Severity Score (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214652


Contacts
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Contact: Study Manager 908-541-8664 Alison.Magnotti-Nagel@bauschhealth.com

Locations
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United States, Arkansas
Bausch Site 205 Not yet recruiting
Rogers, Arkansas, United States, 72758
United States, California
Bausch Site 201 Not yet recruiting
Manhattan Beach, California, United States, 90266
United States, Florida
Bausch Site 207 Not yet recruiting
West Palm Beach, Florida, United States, 33406
United States, Idaho
Bausch Site 208 Not yet recruiting
Boise, Idaho, United States, 83704
United States, Kentucky
Bausch Site 209 Not yet recruiting
Louisville, Kentucky, United States, 40241
United States, Massachusetts
Bausch Site 202 Not yet recruiting
Brighton, Massachusetts, United States, 21350
United States, Michigan
Bausch Site 212 Not yet recruiting
Detroit, Michigan, United States, 48202
United States, New York
Bausch Site 206 Recruiting
New York, New York, United States, 10022
United States, Oregon
Bausch Site 203 Not yet recruiting
Gresham, Oregon, United States, 97030
United States, Rhode Island
Bausch Site 204 Not yet recruiting
Johnston, Rhode Island, United States, 29190
Canada, MN
Bausch Site 213 Not yet recruiting
Winnipeg, MN, Canada, R3M 3Z4
Canada, Ontario
Bausch Site 210 Not yet recruiting
Oakville, Ontario, Canada, L6J 7W5
Bausch Site 211 Not yet recruiting
Peterborough, Ontario, Canada, K9J 5K2
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Bausch Health
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT04214652    
Other Study ID Numbers: V01-126A-302
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases