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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: IDP-123 Lotion; Drug: Tazorac Cream; Drug: Vehicle Lotion; Drug: Vehicle Cream

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Valeant Site 03
    • Fremont, California, United States, 94538
      • Valeant Site 04
    • Los Angeles, California, United States, 90036
      • Valeant Site 06
    • Sacramento, California, United States, 95819
      • Valeant Site 14
    • Santa Monica, California, United States, 90404
      • Valeant Site 01
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
      • Valeant Site 05
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Valeant Site 08
    • Miami, Florida, United States, 33175
      • Valeant Site 10
    • Miramar, Florida, United States, 33027
      • Valeant Site 09
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Valeant Site 12
    • Louisville, Kentucky, United States, 40217
      • Valeant Site 13
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Valeant Site 02
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Valeant Site 07
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Valeant Site 16
    • High Point, North Carolina, United States, 27262
      • Valeant Site 15
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Valeant Site 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IDP-123 Lotion; Lotion	Drug: IDP-123 Lotion; Lotion; Other Names: Lotion
ACTIVE_COMPARATOR: Tazorac Cream; Cream	Drug: Tazorac Cream; Cream; Other Names: Tazorac
ACTIVE_COMPARATOR: Vehicle Lotion; Lotion	Drug: Vehicle Lotion; Lotion; Other Names: Vehicle
ACTIVE_COMPARATOR: Vehicle Cream; Cream	Drug: Vehicle Cream; Cream; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (ESTIMATE): October 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Keratolytic Agents; Tazarotene
• Other Study ID Numbers: V01-123A-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES