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

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

Detailed Description
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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

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: IDP-123 Lotion
* Drug: Tazorac Cream
* Drug: Vehicle Lotion
* Drug: Vehicle Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-123 Lotion<br>Lotion | Drug: IDP-123 Lotion<br>* Lotion<br>* Other names: Lotion;|
| Active Comparator: Tazorac Cream<br>Cream | Drug: Tazorac Cream<br>* Cream<br>* Other names: Tazorac;|
| Active Comparator: Vehicle Lotion<br>Lotion | Drug: Vehicle Lotion<br>* Lotion<br>* Other names: Vehicle;|
| Active Comparator: Vehicle Cream<br>Cream | Drug: Vehicle Cream<br>* Cream<br>* Other names: Vehicle;|

What is the study measuring?
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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 |