Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00835198

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:

MedlinePlus related topics: Acne

Drug Information available for: Dapsone Tretinoin

U.S. FDA Resources

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

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 May 23, 2012