An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

Phase 1

Withdrawn

• Conditions: Acne Vulgaris
• Interventions: Drug: Dapsone Formulation A; Drug: Dapsone Formulation B; Drug: Dapsone Formulation C; Drug: Dapsone 5% Gel

• Registration Number: NCT01785836
• Lead Sponsor: Allergan

Brief Summary

This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25
• Study Start: 2013-03
• Primary Completion: 2013-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participation in Allergan study 225678-004

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Exclusion Criteria

• Anticipates the need for surgery or hospitalization during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapsone Formulation A	Dapsone Formulation A	Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation B	Dapsone Formulation B	Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation C	Dapsone Formulation C	Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone 5% Gel	Dapsone 5% Gel	Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Inflammatory Lesion Count	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Non-Inflammatory Lesion Count	Baseline, Week 12
Change from Baseline in Total Lesion Count	Baseline, Week 12
Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1	Week 12