Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Acne Clinical Trial

Official title:

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965456
• Other study ID #: V01-121A-302
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2015
• Est. completion date: February 23, 2017

Study information

• Verified date: December 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• 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. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).

• Participants must be willing to comply with study instructions and return to the study center for required visits. Participants 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, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the participant 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.

• Participants with a facial beard or mustache that could interfere with the study assessments.

• History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of tretinoin.

• Participants who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.

• Participants with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the participant's safety while participating in the study.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• IDP 121 Lotion
IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
• IDP-121 Vehicle Lotion
IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.

Locations

Country	Name	City	State
United States	Valeant Site 25	Anaheim	California
United States	Valeant Site 10	Austin	Texas
United States	Valeant Site 18	Beverly Hills	California
United States	Valeant Site 16	Buffalo Grove	Illinois
United States	Valeant Site 30	Clarkston	Michigan
United States	Valeant Site 32	Crowley	Louisiana
United States	Valeant Site 03	Detroit	Michigan
United States	Valeant Site 09	Fremont	California
United States	Valeant Site 21	Glendale	Arizona
United States	Valeant Site 29	Hazleton	Pennsylvania
United States	Valeant Site 20	Henderson	Nevada
United States	Valeant Site 01	Houston	Texas
United States	Valeant Site 06	Indianapolis	Indiana
United States	Valeant Site 24	Johnston	Rhode Island
United States	Valeant Site 28	Marietta	Georgia
United States	Valeant Site 11	Miami	Florida
United States	Valeant Site 15	Miami	Florida
United States	Valeant Site 17	Murrieta	California
United States	Valeant Site 08	New York	New York
United States	Valeant Site 12	Overland Park	Kansas
United States	Valeant Site 26	Oxnard	California
United States	Valeant Site 27	Pinellas Park	Florida
United States	Valeant Site 33	Port Arthur	Texas
United States	Valeant Site 34	Rogers	Arkansas
United States	Valeant Site 22	Sacramento	California
United States	Valeant Site 07	San Antonio	Texas
United States	Valeant Site 13	San Antonio	Texas
United States	Valeant Site 14	San Antonio	Texas
United States	Valeant Site 02	San Diego	California
United States	Valeant Site 04	San Diego	California
United States	Valeant Site 31	Sanford	Florida
United States	Valeant Site 19	Santa Monica	California
United States	Valeant Site 05	Tampa	Florida
United States	Valeant Site 23	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12	Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.	Baseline (Day 0), Week 12
Primary	Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12	Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.	Baseline, Week 12
Primary	Percentage of Participants With Treatment Success at Week 12	Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to "Clear" or "Almost Clear". EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.	Baseline, Week 12
Secondary	Percent Change From Baseline in Noninflammatory Lesion Count to Week 12	Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.	Baseline, Week 12
Secondary	Percent Change From Baseline in Inflammatory Lesion Count to Week 12	Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.	Baseline, Week 12