Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.

Detailed Description
-----------------
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Dapsone 5% Gel (SEEGPharm SA) to Aczone® and Both Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris

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

Intervention / Treatment
-----------------
* Drug: Dapsone 5.0% Gel (SEEGPharm)
* Other: Placebo
* Drug: Dapsone 5.0% Gel (Allergan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris. Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization. On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation. Subjects must have an acne severity grade of 3 or 4 per the IGA Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug. Exclusion Criteria: Prior or current concomitant therapies that would interfere with assessments in the study. Prior or current concomitant therapies skin conditions that would interfere with assessments in the study. Prior, current or planned procedures that would interfere with assessments in the study. Current or planned activities that would interfere with assessment in the study. Subjects who have a Baseline local skin site reaction score of 3 [severe (marked/intense)] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapsone 5.0% Gel (Allergan)<br>Dapsone 5.0% Gel applied twice daily for 84 days | Drug: Dapsone 5.0% Gel (Allergan)<br>* Topical Gel<br>* Other names: Active Comparator;|
| Experimental: Dapsone 5.0% Gel (SEEGPharm)<br>Dapsone 5.0% Gel applied twice daily for 84 days | Drug: Dapsone 5.0% Gel (SEEGPharm)<br>* Topical Gel<br>* Other names: Experimental Arm;|
| Placebo Comparator: Placebo<br>Vehicle of Experimental Gel applied twice daily for 84 days | Other: Placebo<br>* Topical Gel<br>* Other names: Placebo Comparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts | To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT) | Treatment Days: 84 days of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success: Proportion of subjects with a clinical response of success | To evaluate as the proportion of subjects with a clinical response of success at Week 12. | 12 Weeks |