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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: IDP-126 Gel; Drug: IDP-126 Vehicle Gel

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Bausch Site 101
    • Waterloo, Ontario, Canada, N2J 1C4
      • Bausch Site 113
• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Bausch Site 110
  • California
    • Fremont, California, United States, 94538
      • Bausch Site 104
  • Colorado
    • Denver, Colorado, United States, 80220
      • Bausch Site 109
  • Florida
    • Boynton Beach, Florida, United States, 33463
      • Bausch Site 102
    • North Miami Beach, Florida, United States, 33162
      • Bausch Site 111
    • Sanford, Florida, United States, 32771
      • Bausch Site 106
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Bausch Site 103
  • New York
    • New York, New York, United States, 10075
      • Bausch Site 114
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Bausch Site 105
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Bausch Site 107
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Bausch Site 108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts		12 weeks
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts		12 weeks
Percentage of Participants With Success on the Evaluator's Global Severity Score	Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12		Baseline to Week 4, 8, 12
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12		Baseline to Week 4, 8, 12
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.	12 weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Anya Loncaric, Bausch Health

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Actual): January 18, 2021
• Study Completion (Actual): January 18, 2021

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: V01-126A-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No