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A 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


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) Scale

Change from Baseline in Inflammatory Facial Lesion Counts

Change from Baseline in Noninflammatory Facial Lesion Counts

Secondary outcome:

Change from Baseline in Total Lesion Counts

Percentage 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


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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

Encino, California, United States

North Bay, Ontario, Canada

Additional Information

Study Website

Starting date: November 2013
Last updated: November 17, 2014

Page last updated: August 20, 2015

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