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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: IDP 120 Vehicle Gel; Drug: IDP-120 Gel; Drug: IDP 120 Component A Gel; Drug: IDP 120 Component B Gel

• Registration Number: NCT03003247
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

Detailed Description

A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-05-06
• Primary Completion: 2016-08-31
• Study Completion: 2016-09-30
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Status Verified: 2017-12
• Disposition First Submitted: 2017-12-13
• Disposition First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Disposition First Posted: 2017-12-18
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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)
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
• Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
• If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.

Key

Exclusion Criteria

• Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
• 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, gramnegative folliculitis.
• 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 a facial beard or mustache that could interfere with the study assessments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDP-120 Vehicle Gel	IDP 120 Vehicle Gel	IDP-120 Vehicle Gel
IDP-120 Gel	IDP-120 Gel	IDP-120 Gel is a combination treatment
IDP-120 Component A Gel	IDP 120 Component A Gel	IDP-120 Monad Gel of Component A
IDP-120 Component B Gel	IDP 120 Component B Gel	IDP-120 Monad Gel of Component B

Primary Outcome Measures

Name	Time	Method
Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.	12 Weeks	Percent 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.

Trial Locations

Locations (24)

Valeant Site 15; 🇺🇸 Encino, California, United States

Valeant Site 13; 🇺🇸 Lake Mary, Florida, United States

Valeant Site 14; 🇺🇸 Tampa, Florida, United States

Valeant Site 02; 🇺🇸 West Palm Beach, Florida, United States

Valeant Site 21; 🇺🇸 Atlanta, Georgia, United States

Valeant Site 23; 🇺🇸 South Bend, Indiana, United States

Valeant Site 11; 🇺🇸 Saint Joseph, Missouri, United States

Valreant Site 05; 🇺🇸 New York, New York, United States

Valeant Site 06; 🇺🇸 New York, New York, United States

Valeant Site 01; 🇺🇸 Chapel Hill, North Carolina, United States

Valeant Site 07; 🇺🇸 Austin, Texas, United States

Valeant Site 17; 🇺🇸 High Point, North Carolina, United States

Valeant Site 25; 🇺🇸 Spokane, Washington, United States

Valeant Site 12; 🇺🇸 Austin, Texas, United States

Valeant Site 03; 🇨🇦 Markham, Ontario, Canada

Valeant Site 08; 🇨🇦 Waterloo, Ontario, Canada

Valeant Site 20; 🇨🇦 Windsor, Ontario, Canada

Valeant Site 16; 🇺🇸 Miami, Florida, United States

Valeant Site 24; 🇺🇸 Minneapolis, Minnesota, United States

Valeant Site 22; 🇺🇸 Columbus, Ohio, United States

Valeant Site 18; 🇺🇸 San Antonio, Texas, United States

Valeant Site 10; 🇨🇦 Winnepeg, Manitoba, Canada

Valeant Site 09; 🇺🇸 Detroit, Michigan, United States

Valeant Site 04; 🇺🇸 Knoxville, Tennessee, United States