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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938494
• Other study ID #: V01-123A-201
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• IDP-123 Lotion
Lotion
• Tazorac Cream
Cream
• Vehicle Lotion
Lotion
• Vehicle Cream
Cream

Locations

Country	Name	City	State
United States	Valeant Site 16	Chapel Hill	North Carolina
United States	Valeant Site 05	Colorado Springs	Colorado
United States	Valeant Site 08	Coral Gables	Florida
United States	Valeant Site 03	Encinitas	California
United States	Valeant Site 04	Fremont	California
United States	Valeant Site 07	Fridley	Minnesota
United States	Valeant Site 15	High Point	North Carolina
United States	Valeant Site 06	Los Angeles	California
United States	Valeant Site 12	Louisville	Kentucky
United States	Valeant Site 13	Louisville	Kentucky
United States	Valeant Site 10	Miami	Florida
United States	Valeant Site 09	Miramar	Florida
United States	Valeant Site 11	Philadelphia	Pennsylvania
United States	Valeant Site 02	Rockville	Maryland
United States	Valeant Site 14	Sacramento	California
United States	Valeant Site 01	Santa Monica	California

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