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A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01974141
First received: October 28, 2013
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.


Condition Intervention Phase
Acne Vulgaris
Drug: Dapsone Gel
Drug: Dapsone Gel Vehicle
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients with None or Minimal on the 5-Point Global Acne Assessment Score (GAAS) Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Inflammatory Facial Lesion Counts [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Noninflammatory Facial Lesion Counts [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Total Lesion Counts [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage Change from Baseline in Lesion Counts [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients Reporting "Very Good" or "Excellent" in the Assessment of Facial Appearance on a 5-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in the 9-Item Acne Symptom and Impact Scale (ASIS) Sign Domain Score [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients Reporting at Least a 1-Grade Improvement from Baseline in Oiliness on a 5-Point Scale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients Reporting at Least a 1-Grade Improvement from Baseline in Redness on a 5-Point Scale [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Enrollment: 2156
Study Start Date: November 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapsone Gel
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Drug: Dapsone Gel
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Placebo Comparator: Dapsone Gel Vehicle
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Drug: Dapsone Gel Vehicle
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974141

Locations
United States, California
Encino, California, United States
Canada, Ontario
North Bay, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01974141     History of Changes
Other Study ID Numbers: 225678-006
Study First Received: October 28, 2013
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Dapsone
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014