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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: IDP-120 Gel; Drug: IDP 120 Component A Gel; Drug: IDP 120 Component B Gel; Drug: IDP 120 Vehicle Gel

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 Type: Interventional
• Enrollment (Actual): 364
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnepeg, Manitoba, Canada, R2C 0A1
      • Valeant Site 10
  • Ontario
    • Markham, Ontario, Canada, L3P 0A1
      • Valeant Site 03
    • Waterloo, Ontario, Canada, N2J 1L9
      • Valeant Site 08
    • Windsor, Ontario, Canada, N9A 2S6
      • Valeant Site 20
• United States
  • California
    • Encino, California, United States, 91316
      • Valeant Site 15
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Valeant Site 13
    • Miami, Florida, United States, 33101
      • Valeant Site 16
    • Tampa, Florida, United States, 33601
      • Valeant Site 14
    • West Palm Beach, Florida, United States, 33401
      • Valeant Site 02
  • Georgia
    • Atlanta, Georgia, United States, 30302
      • Valeant Site 21
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Valeant Site 23
  • Michigan
    • Detroit, Michigan, United States, 48204
      • Valeant Site 09
  • Minnesota
    • Minneapolis, Minnesota, United States, 55401
      • Valeant Site 24
  • Missouri
    • Saint Joseph, Missouri, United States, 64502
      • Valeant Site 11
  • New York
    • New York, New York, United States, 10001
      • Valreant Site 05
    • New York, New York, United States, 10002
      • Valeant Site 06
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Valeant Site 01
    • High Point, North Carolina, United States, 27268
      • Valeant Site 17
  • Ohio
    • Columbus, Ohio, United States, 43085
      • Valeant Site 22
  • Tennessee
    • Knoxville, Tennessee, United States, 37901
      • Valeant Site 04
  • Texas
    • Austin, Texas, United States, 73301
      • Valeant Site 07
    • Austin, Texas, United States, 78701
      • Valeant Site 12
    • San Antonio, Texas, United States, 78204
      • Valeant Site 18
  • Washington
    • Spokane, Washington, United States, 99202
      • Valeant Site 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDP-120 Gel; IDP-120 Gel is a combination treatment	Drug: IDP-120 Gel; IDP-120 Gel is a combination product; Other Names: Component A + B
Active Comparator: IDP-120 Component A Gel; IDP-120 Monad Gel of Component A	Drug: IDP 120 Component A Gel; Monad of Component A; Other Names: Component A
Active Comparator: IDP-120 Component B Gel; IDP-120 Monad Gel of Component B	Drug: IDP 120 Component B Gel; Monad of Component B; Other Names: Component B
Placebo Comparator: IDP-120 Vehicle Gel	Drug: IDP 120 Vehicle Gel; Vehicle; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.	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.	12 Weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): September 30, 2016

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: V01-120A-201

Plan for Individual participant data (IPD)

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