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

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Dapsone Gel

• Registration Number: NCT02032407
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-10
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Results First Submitted: 2015-06-15
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-11
• Last Update Submitted: 2015-08-11
• Results First Posted: 2015-08-19
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

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Exclusion Criteria

• Received treatment with botulinum toxin of any serotype in the face within 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapsone Gel	Dapsone Gel	Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician	Baseline, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the GAAS	Baseline, Weeks 2 and 6	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.
Percent Change From Baseline in Total Lesion Counts	Baseline, Weeks 2, 6 and 12	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).
Percent Change From Baseline in Inflammatory Lesion Counts	Baseline, Weeks 2, 6 and 12	The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Percent Change From Baseline in Non-Inflammatory Lesion Counts	Baseline, Weeks 2, 6 and 12	The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).
Acne Symptom and Impact Scale (ASIS) Sign Domain Score	Weeks 2, 6 and 12	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.
ASIS Impact Domain Score	Weeks 2, 6 and 12	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.
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS	Weeks 2, 6 and 12	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.