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

NCT ID: NCT03664739

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2020-03-23

Brief Summary

study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel

Detailed Description

This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IDP-120 Gel

IDP-120 Gel, once-daily application

Group Type: EXPERIMENTAL

IDP-120 Gel

Intervention Type: DRUG

IDP-120 Gel, once-daily application

IDP-120 Vehicle Gel

IDP-120 Vehicle Gel, once-daily application

Group Type: PLACEBO_COMPARATOR

IDp-120 Vehicle Gel

Intervention Type: DRUG

IDP-120 Vehicle Gel, once-daily application

Interventions

IDP-120 Gel

IDP-120 Gel, once-daily application

Intervention Type: DRUG

IDp-120 Vehicle Gel

IDP-120 Vehicle Gel, once-daily application

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. 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);

3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS) assessment at the baseline visit;

4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;

5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;

6. Subjects with two or fewer facial nodules

Exclusion Criteria

1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study;

2. 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;

3. 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;

4. Subjects with a facial beard or mustache that could interfere with the study assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Bausch Health Companies

Locations

Valeant Site 123

Mobile, Alabama, United States

Valeant Site 121

Hot Springs, Arkansas, United States

Valeant Site 120

Beverly Hills, California, United States

Valeant Site 117

Encinitas, California, United States

Valeant Site 107

Fremont, California, United States

Valeant Site 104

San Diego, California, United States

Valeant Site 128

Denver, Colorado, United States

Valeant Site 115

Wheat Ridge, Colorado, United States

Valeant Site 113

Clearwater, Florida, United States

Valeant Site 122

North Miami Beach, Florida, United States

Valeant Site 103

West Palm Beach, Florida, United States

Valeant Site 101

Oakbrook Terrace, Illinois, United States

Valeant Site 124

Evansville, Indiana, United States

Valeant Site 111

Louisville, Kentucky, United States

Valeant Site 118

Largo, Maryland, United States

Valeant Site 129

Needham, Massachusetts, United States

Valeant Site 119

Detroit, Michigan, United States

Valeant Site 126

New York, New York, United States

Valeant Site 108

High Point, North Carolina, United States

Valeant Site 106

Oklahoma City, Oklahoma, United States

Valeant Site 109

Austin, Texas, United States

Valeant Site 130

Pflugerville, Texas, United States

Valeant Site 105

San Antonio, Texas, United States

Valeant Site 110

Norfolk, Virginia, United States

Valeant Site 116

Walla Walla, Washington, United States

Valeant Site 112

Markham, Ontario, Canada

Valeant Site 102

Waterloo, Ontario, Canada

Valeant Site 114

Waterloo, Ontario, Canada

Valeant Site 125

Waterloo, Ontario, Canada

Valeant Site 127

Waterloo, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V01-120A-301

Identifier Type: -

Identifier Source: org_study_id