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:	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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

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:

Inflammatory lesion counts (papules/pustules) [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator global assessment [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
Overall disease severity [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
Inflamed lesion counts (nodules) [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
Non-inflamed lesions counts (open/closed comedones) [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator Tretinoin gel 0.025%	Drug: Tretinoin Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks

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, Inc. ( Vice President Medical Affairs )
Study ID Numbers:	MA-ACZ0801
Study First Received:	January 30, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00835198 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Facial Dermatoses
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Enzyme Inhibitors
Sebaceous Gland Diseases
Folic Acid Antagonists
Acne Vulgaris
Pharmacologic Actions

Keratolytic Agents
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Acneiform Eruptions
Therapeutic Uses
Dapsone
Tretinoin
Dermatologic Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on February 08, 2010