An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris
Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
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Status: Withdrawn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
Summary
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with
acne vulgaris following 12 weeks of treatment.
Clinical Details
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 CountChange from Baseline in Total Lesion Count Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1
Eligibility
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
Locations and Contacts
Additional Information
Starting date: March 2013
Last updated: February 22, 2013
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