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

• ClinicalTrials.gov Identifier: NCT02938494
• Recruitment Status: Completed
• First Posted: October 19, 2016
• Results First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: IDP-123 Lotion; Drug: Tazorac Cream; Drug: Vehicle Lotion; Drug: Vehicle Cream	Phase 2

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, in the Treatment of Acne Vulgaris
• Study Start Date: November 2015
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: IDP-123 Lotion; Lotion	Drug: IDP-123 Lotion; Lotion; Other Name: Lotion
Active Comparator: Tazorac Cream; Cream	Drug: Tazorac Cream; Cream; Other Name: Tazorac
Active Comparator: Vehicle Lotion; Lotion	Drug: Vehicle Lotion; Lotion; Other Name: Vehicle
Active Comparator: Vehicle Cream; Cream	Drug: Vehicle Cream; Cream; Other Name: Vehicle

Outcome Measures

Primary Outcome Measures :

1. Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 [ Time Frame: Baseline (Day 0), 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.
2. Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 [ Time Frame: Baseline, 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.
3. Percentage of Participants With Treatment Success at Week 12 [ Time Frame: Baseline, 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key 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.

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, 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.

Contacts and Locations

Locations

United States, California

Valeant Site 03

Encinitas, California, United States, 92024

Valeant Site 04

Fremont, California, United States, 94538

Valeant Site 06

Los Angeles, California, United States, 90036

Valeant Site 14

Sacramento, California, United States, 95819

Valeant Site 01

Santa Monica, California, United States, 90404

United States, Colorado

Valeant Site 05

Colorado Springs, Colorado, United States, 80915

United States, Florida

Valeant Site 08

Coral Gables, Florida, United States, 33146

Valeant Site 10

Miami, Florida, United States, 33175

Valeant Site 09

Miramar, Florida, United States, 33027

United States, Kentucky

Valeant Site 12

Louisville, Kentucky, United States, 40202

Valeant Site 13

Louisville, Kentucky, United States, 40217

United States, Maryland

Valeant Site 02

Rockville, Maryland, United States, 20850

United States, Minnesota

Valeant Site 07

Fridley, Minnesota, United States, 55432

United States, North Carolina

Valeant Site 16

Chapel Hill, North Carolina, United States, 27517

Valeant Site 15

High Point, North Carolina, United States, 27262

United States, Pennsylvania

Valeant Site 11

Philadelphia, Pennsylvania, United States, 19103

Sponsors and Collaborators

Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric; Valeant Pharmaceuticals

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT02938494
• Other Study ID Numbers: V01-123A-201
• First Posted: October 19, 2016
• Results First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Tazarotene; Dermatologic Agents; Keratolytic Agents