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

NCT ID: NCT03664752

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 585 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2020-05-07

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 210

Rogers, Arkansas, United States

Valeant Site 201

Manhattan Beach, California, United States

Valeant Site 206

San Diego, California, United States

Valeant Site 218

San Diego, California, United States

Valeant Site 204

Boynton Beach, Florida, United States

Valeant Site 217

Brandon, Florida, United States

Valeant Site 202S

Miami, Florida, United States

Valeant Site 214

Tampa, Florida, United States

Valeant Site 222

Snellville, Georgia, United States

Valeant Site 215

Boise, Idaho, United States

Valeant Site 205

Metairie, Louisiana, United States

Valeant Site 216

Clarkston, Michigan, United States

Valeant Site 221

Clinton Township, Michigan, United States

Valeant Site 227

Rochester, New York, United States

Valeant Site 229

Raleigh, North Carolina, United States

Valeant Site 230

Raleigh, North Carolina, United States

Valeant Site 213

San Antonio, Texas, United States

Valeant Site 223

Spokane, Washington, United States

Valeant Site 219

Waterloo, Ontario, Canada

Valeant Site 228

Waterloo, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

V01-120A-302

Identifier Type: -

Identifier Source: org_study_id