A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

Study Overview
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Brief Summary
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This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Dapsone Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of acne vulgaris Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI) Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study Exclusion Criteria: Received treatment with botulinum toxin of any serotype in the face within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapsone Gel<br>Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks. | Drug: Dapsone Gel<br>* Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.<br>* Other names: Aczone®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician | The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the GAAS | The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement. | Baseline, Weeks 2 and 6 | 
| Percent Change From Baseline in Total Lesion Counts | The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Weeks 2, 6 and 12 | 
| Percent Change From Baseline in Inflammatory Lesion Counts | The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Weeks 2, 6 and 12 | 
| Percent Change From Baseline in Non-Inflammatory Lesion Counts | The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Weeks 2, 6 and 12 | 
| Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS | The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported. | Weeks 2, 6 and 12 | 
| Acne Symptom and Impact Scale (ASIS) Sign Domain Score | The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne. | Weeks 2, 6 and 12 | 
| ASIS Impact Domain Score | The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance. | Weeks 2, 6 and 12 |