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

NCT03003247 | Completed Phase 2

• 1 other identifier: V01-120A-201
• Study Type: interventional
• Target: 364
• Locations: 2 countries
• Sites: 24

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

IDP-120 Gel

EXPERIMENTAL

IDP-120 Gel is a combination treatment

Drug: IDP-120 Gel

IDP-120 Component A Gel

ACTIVE COMPARATOR

IDP-120 Monad Gel of Component A

Drug: IDP 120 Component A Gel

IDP-120 Component B Gel

ACTIVE COMPARATOR

IDP-120 Monad Gel of Component B

Drug: IDP 120 Component B Gel

IDP-120 Vehicle Gel

PLACEBO COMPARATOR

IDP-120 Vehicle Gel

Drug: IDP 120 Vehicle Gel

Interventions

IDP-120 Gel DRUG

IDP-120 Gel is a combination product

Also known as: Component A + B

IDP-120 Gel

IDP 120 Component A Gel DRUG

Monad of Component A

Also known as: Component A

IDP-120 Component A Gel

IDP 120 Component B Gel DRUG

Monad of Component B

Also known as: Component B

IDP-120 Component B Gel

IDP 120 Vehicle Gel DRUG

Vehicle

Also known as: Vehicle

IDP-120 Vehicle Gel

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (24)

Valeant Site 15

Encino, California, 91316, United States

Location

Valeant Site 13

Lake Mary, Florida, 32746, United States

Location

Valeant Site 16

Miami, Florida, 33101, United States

Location

Valeant Site 14

Tampa, Florida, 33601, United States

Location

Valeant Site 02

West Palm Beach, Florida, 33401, United States

Location

Valeant Site 21

Atlanta, Georgia, 30302, United States

Location

Valeant Site 23

South Bend, Indiana, 46601, United States

Location

Valeant Site 09

Detroit, Michigan, 48204, United States

Location

Valeant Site 24

Minneapolis, Minnesota, 55401, United States

Location

Valeant Site 11

Saint Joseph, Missouri, 64502, United States

Location

Valreant Site 05

New York, New York, 10001, United States

Location

Valeant Site 06

New York, New York, 10002, United States

Location

Valeant Site 01

Chapel Hill, North Carolina, 27517, United States

Location

Valeant Site 17

High Point, North Carolina, 27268, United States

Location

Valeant Site 22

Columbus, Ohio, 43085, United States

Location

Valeant Site 04

Knoxville, Tennessee, 37901, United States

Location

Valeant Site 07

Austin, Texas, 73301, United States

Location

Valeant Site 12

Austin, Texas, 78701, United States

Location

Valeant Site 18

San Antonio, Texas, 78204, United States

Location

Valeant Site 25

Spokane, Washington, 99202, United States

Location

Valeant Site 10

Winnepeg, Manitoba, R2C 0A1, Canada

Location

Valeant Site 03

Markham, Ontario, L3P 0A1, Canada

Location

Valeant Site 08

Waterloo, Ontario, N2J 1L9, Canada

Location

Valeant Site 20

Windsor, Ontario, N9A 2S6, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

methane monooxygenase

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Anya Loncaric

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: December 26, 2016
• Study Start: November 1, 2015
• Primary Completion: August 31, 2016
• Study Completion: September 30, 2016
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); US (20)