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

Condition(s) targeted: Acne Vulgaris

Intervention: Dapsone Formulation A (Drug); Dapsone Formulation B (Drug); Dapsone Formulation C (Drug); Dapsone 5% Gel (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from Baseline in Inflammatory Lesion Count

Secondary outcome:

Change from Baseline in Non-Inflammatory Lesion Count

Change from Baseline in Total Lesion Count

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

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participation in Allergan study 225678-004

Exclusion Criteria:

- Anticipates the need for surgery or hospitalization during the study

Starting date: March 2013
Last updated: February 22, 2013