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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003247
• Other study ID #: V01-120A-201
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2016
• Last updated: December 14, 2017
• Start date: November 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: December 2017
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: September 30, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• IDP-120 Gel
IDP-120 Gel is a combination product
• IDP 120 Component A Gel
Monad of Component A
• IDP 120 Component B Gel
Monad of Component B
• IDP 120 Vehicle Gel
Vehicle

Locations

Country	Name	City	State
Canada	Valeant Site 03	Markham	Ontario
Canada	Valeant Site 08	Waterloo	Ontario
Canada	Valeant Site 20	Windsor	Ontario
Canada	Valeant Site 10	Winnepeg	Manitoba
United States	Valeant Site 21	Atlanta	Georgia
United States	Valeant Site 07	Austin	Texas
United States	Valeant Site 12	Austin	Texas
United States	Valeant Site 01	Chapel Hill	North Carolina
United States	Valeant Site 22	Columbus	Ohio
United States	Valeant Site 09	Detroit	Michigan
United States	Valeant Site 15	Encino	California
United States	Valeant Site 17	High Point	North Carolina
United States	Valeant Site 04	Knoxville	Tennessee
United States	Valeant Site 13	Lake Mary	Florida
United States	Valeant Site 16	Miami	Florida
United States	Valeant Site 24	Minneapolis	Minnesota
United States	Valeant Site 06	New York	New York
United States	Valreant Site 05	New York	New York
United States	Valeant Site 11	Saint Joseph	Missouri
United States	Valeant Site 18	San Antonio	Texas
United States	Valeant Site 23	South Bend	Indiana
United States	Valeant Site 25	Spokane	Washington
United States	Valeant Site 14	Tampa	Florida
United States	Valeant Site 02	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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