Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00834210

Purpose

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe facial acne vulgaris

Condition	Intervention	Phase
Acne Vulgaris	Drug: Dapsone Drug: Tazarotene	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 Tazarotene

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Inflamed 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 lesion 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 Tazarotene Cream 0.1%	Drug: Dapsone Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
2: Active Comparator Tazarotene Cream 0.1%	Drug: Tazarotene Tazarotene Cream 0.1%, 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, 3 or more nodules and/or cysts (diameter of 1cm or greater). 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: NCT00834210

Locations

United States, California

Fremont, California, 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-ACZ0802
Study First Received:	January 30, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00834210 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
Physiological Effects of Drugs
Sebaceous Gland Diseases
Acne Vulgaris
Keratolytic Agents
Antimalarials
Nicotinic Acids
Anti-Bacterial Agents
Antiparasitic Agents
Acneiform Eruptions

Therapeutic Uses
Vitamins
Dapsone
Micronutrients
Dermatologic Agents
Tazarotene
Vitamin B Complex
Skin Diseases
Growth Substances
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Leprostatic Agents

ClinicalTrials.gov processed this record on February 08, 2010