Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

NCT ID: NCT02938494

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-09-30

Brief Summary

Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Detailed Description

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion (0.045% tazarotene) to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IDP-123 Lotion

Lotion

Group Type: EXPERIMENTAL

IDP-123 Lotion

Intervention Type: DRUG

Lotion

Tazorac Cream

Cream

Group Type: ACTIVE_COMPARATOR

Tazorac Cream

Intervention Type: DRUG

Cream

Vehicle Lotion

Lotion

Group Type: ACTIVE_COMPARATOR

Vehicle Lotion

Intervention Type: DRUG

Lotion

Vehicle Cream

Cream

Group Type: ACTIVE_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Cream

Interventions

IDP-123 Lotion

Lotion

Intervention Type: DRUG

Tazorac Cream

Cream

Intervention Type: DRUG

Vehicle Lotion

Lotion

Intervention Type: DRUG

Vehicle Cream

Cream

Intervention Type: DRUG

Other Intervention Names

Lotion; Tazorac; Vehicle; Vehicle

Eligibility Criteria

Inclusion Criteria

• Male or female at least 12 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).
• Women of childbearing potential and females that are pre-menses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study. Women who use birth control for acne control only should be excluded.
• Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits.

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, dermatitis, eczema.
• 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.
• Evidence or history of cosmetic-related acne.
• Subject has a history of experiencing significant burning or stinging when applying any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

Valeant Site 03

Encinitas, California, United States

Valeant Site 04

Fremont, California, United States

Valeant Site 06

Los Angeles, California, United States

Valeant Site 14

Sacramento, California, United States

Valeant Site 01

Santa Monica, California, United States

Valeant Site 05

Colorado Springs, Colorado, United States

Valeant Site 08

Coral Gables, Florida, United States

Valeant Site 10

Miami, Florida, United States

Valeant Site 09

Miramar, Florida, United States

Valeant Site 12

Louisville, Kentucky, United States

Valeant Site 13

Louisville, Kentucky, United States

Valeant Site 02

Rockville, Maryland, United States

Valeant Site 07

Fridley, Minnesota, United States

Valeant Site 16

Chapel Hill, North Carolina, United States

Valeant Site 15

High Point, North Carolina, United States

Valeant Site 11

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

V01-123A-201

Identifier Type: -

Identifier Source: org_study_id