Safety and Efficacy Study of Dapsone Gel in Patients With 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 Gel (Drug); Dapsone Gel Vehicle (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
Summary
This study will assess the safety and efficacy of dapsone gel versus vehicle control in
patients with acne vulgaris.
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: Percentage of Patients with None or Minimal on the 5-Point Global Acne Assessment Score (GAAS) ScaleChange from Baseline in Inflammatory Facial Lesion Counts Change from Baseline in Noninflammatory Facial Lesion Counts
Secondary outcome: Change from Baseline in Total Lesion CountsPercentage Change from Baseline in Lesion Counts Percentage of Patients Reporting "Very Good" or "Excellent" in the Assessment of Facial Appearance on a 5-Point Scale Change from Baseline in the 9-Item Acne Symptom and Impact Scale (ASIS) Sign Domain Score Percentage of Patients Reporting at Least a 1-Grade Improvement from Baseline in Oiliness on a 5-Point Scale Percentage of Patients Reporting at Least a 1-Grade Improvement from Baseline in Redness on a 5-Point Scale
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of acne vulgaris
- Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight,
tanning beds) throughout the study
Exclusion Criteria:
- Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
- Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive
cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling,
comedo extraction) in the past week
- Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics,
antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]),
retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps
such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium
sulfacetamide) in the past 2 weeks
- Use of birth control pills strictly for acne control
Locations and Contacts
Beverly Hills, California, United States
Aventura, Florida, United States
Windsor, Ontario, Canada
Additional Information
Study Website
Starting date: November 2013
Last updated: November 17, 2014
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