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

Allergan

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Acne Vulgaris

Interventions

Dapsone Formulation ADRUG

Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Dapsone Formulation BDRUG

Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Dapsone Formulation CDRUG

Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participation in Allergan study 225678-004 Exclusion Criteria: * Anticipates the need for surgery or hospitalization during the study

Outcomes

Primary Outcomes

Change from Baseline in Inflammatory Lesion Count

Time frame: Baseline, Week 12

Secondary Outcomes

Change from Baseline in Non-Inflammatory Lesion Count

Time frame: Baseline, Week 12

Change from Baseline in Total Lesion Count

Time frame: Baseline, Week 12

Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1

Time frame: Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.