Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00835198
First received: January 30, 2009
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris


Condition Intervention Phase
Acne Vulgaris
Drug: Dapsone; Tretinoin
Drug: Tretinoin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).


Secondary Outcome Measures:
  • Change From Baseline in Investigator Global Assessment at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).

  • Change From Baseline in Overall Disease Severity at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).

  • Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).


Enrollment: 163
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Dapsone gel 5% and Tretinoin gel 0.025%
Drug: Dapsone; Tretinoin
Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
Other Name: Aczone Gel 5%; Tretin-X Gel 0.025%
Active Comparator: 2
Tretinoin gel 0.025%
Drug: Tretinoin
Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks
Other Name: Tretin-X Gel 0.025%

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Facial acne vulgaris characterized by the following:

    • 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
    • Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
  • Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

  • Non-compliance with washout period;
  • History of clinically significant anemia or hemolysis;
  • Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
  • Allergy or sensitivity to any component of the test medications
  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: NCT00835198

Locations
United States, Ohio
Strongsville, Ohio, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00835198     History of Changes
Other Study ID Numbers: MA-ACZ0801
Study First Received: January 30, 2009
Results First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014