Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel

Study Overview
=================
Brief Summary
-----------------
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.

Detailed Description
-----------------
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.

Official Title
-----------------
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: IDP-126 Gel
* Drug: IDP-126 Vehicle Gel
* Drug: Epiduo® Forte Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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). Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150. Subjects with 2 or fewer facial nodules. Exclusion Criteria: 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, gram negative 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 more than 2 facial nodules. Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study. Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area. Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area. Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications. Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-126 Gel<br> | Drug: IDP-126 Gel<br>* Gel applied to face once daily in the evening.<br>* Other names: IDP-126;|
| Placebo Comparator: IDP-126 Vehicle Gel<br> | Drug: IDP-126 Vehicle Gel<br>* Gel applied to face once daily in the evening.<br>* Other names: Vehicle;|
| Active Comparator: Epiduo® Forte Gel<br> | Drug: Epiduo® Forte Gel<br>* Gel applied to face once daily in the evening.<br>* Other names: Epiduo® Forte;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from Baseline to Week 12 in lesion counts. |  | Baseline to Week 12 | 
| Percentage of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe. | Baseline to Week 12 |