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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Vehicle Lotion; Drug: Vehicle Cream; Drug: IDP-123 Lotion; Drug: Tazorac Cream

• Registration Number: NCT02938494
• Lead Sponsor: Bausch Health Americas, Inc.

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

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Disposition First Submitted: 2018-01-16
• Disposition First Submitted QC: 2018-01-16
• Disposition First Posted: 2018-01-18
• Results First Submitted: 2020-08-08
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Results First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle Lotion	Vehicle Lotion	Lotion
Vehicle Cream	Vehicle Cream	Cream
IDP-123 Lotion	IDP-123 Lotion	Lotion
Tazorac Cream	Tazorac Cream	Cream

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12	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.
Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12	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.
Percentage of Participants With Treatment Success at Week 12	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.

Trial Locations

Locations (16)

Valeant Site 06; 🇺🇸 Los Angeles, California, United States

Valeant Site 11; 🇺🇸 Philadelphia, Pennsylvania, United States

Valeant Site 01; 🇺🇸 Santa Monica, California, United States

Valeant Site 14; 🇺🇸 Sacramento, California, United States

Valeant Site 07; 🇺🇸 Fridley, Minnesota, United States

Valeant Site 04; 🇺🇸 Fremont, California, United States

Valeant Site 03; 🇺🇸 Encinitas, California, United States

Valeant Site 05; 🇺🇸 Colorado Springs, Colorado, United States

Valeant Site 08; 🇺🇸 Coral Gables, Florida, United States

Valeant Site 09; 🇺🇸 Miramar, Florida, United States

Valeant Site 10; 🇺🇸 Miami, Florida, United States

Valeant Site 15; 🇺🇸 High Point, North Carolina, United States

Valeant Site 12; 🇺🇸 Louisville, Kentucky, United States

Valeant Site 13; 🇺🇸 Louisville, Kentucky, United States

Valeant Site 16; 🇺🇸 Chapel Hill, North Carolina, United States

Valeant Site 02; 🇺🇸 Rockville, Maryland, United States