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

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04214639
Collaborator
(none)
183
13
2
12.1
14.1
1.2

Study Details

Study Description

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
  • Drug: IDP-126 Gel
  • Drug: IDP-126 Vehicle Gel
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
183 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 :
Jan 17, 2020
Actual Primary Completion Date :
Jan 18, 2021
Actual Study Completion Date :
Jan 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

  2. Absolute change from Baseline to Week 12 in non-inflammatory lesion counts [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) [12 weeks]

    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:
9 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bausch Site 110 Bryant Arkansas United States 72022
2 Bausch Site 104 Fremont California United States 94538
3 Bausch Site 109 Denver Colorado United States 80220
4 Bausch Site 102 Boynton Beach Florida United States 33463
5 Bausch Site 111 North Miami Beach Florida United States 33162
6 Bausch Site 106 Sanford Florida United States 32771
7 Bausch Site 103 Las Vegas Nevada United States 89148
8 Bausch Site 114 New York New York United States 10075
9 Bausch Site 105 High Point North Carolina United States 27262
10 Bausch Site 107 Nashville Tennessee United States 37215
11 Bausch Site 108 Pflugerville Texas United States 78660
12 Bausch Site 101 Barrie Ontario Canada L4M 7G1
13 Bausch Site 113 Waterloo Ontario Canada N2J 1C4

Sponsors and Collaborators

  • Bausch Health Americas, Inc.

Investigators

  • Study Director: Anya Loncaric, Bausch Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT04214639
Other Study ID Numbers:
  • V01-126A-301
First Posted:
Jan 2, 2020
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 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 Jan 20, 2022