Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

Study Overview
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Brief Summary
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To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Detailed Description
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This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Official Title
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Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris

Conditions
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Acne

Intervention / Treatment
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* Drug: Dapsone 7.5 % gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects of any race and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study. Truncal acne IGA score of 3. Able to understand the requirements of study and sign Informed Consent/HIPAA forms. Exclusion Criteria: Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control. Subjects who have an allergy or sensitivity to any component of the test medication. Subjects who have not complied with the proper wash out periods for prohibited medications. Evidence of recent drug or alcohol abuse. Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne. Exposure to an investigational drug within 30 days of the Baseline visit. Medical condition that contraindicates the subject's participation in the study. History of poor cooperation, non-compliance with medical treatment or unreliability.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapsone gel 7.5%<br>Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks. | Drug: Dapsone 7.5 % gel<br>* Dapsone gel 7.5% applied once daily to truncal acne<br>* Other names: Aczone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale | Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline |  | 16 Weeks | 
| The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline |  | 16 Weeks | 
| The Percent Change in Total Lesion Count at Week 16 Compared to Baseline |  | 16 Weeks |