- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00834210
Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris
September 22, 2011 updated by: Allergan
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Fremont, California, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Dapsone Gel 5% and Tazarotene Cream 0.1%
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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
Other Names:
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Active Comparator: 2
Tazarotene Cream 0.1%
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Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12
Time Frame: Baseline, Week 12
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Change from baseline in inflammatory lesion count (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).
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Investigator Global Assessment at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change From Baseline in Overall Disease Severity at Week 12
Time Frame: Baseline, Week 12
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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).
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Baseline, Week 12
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Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Time Frame: Baseline, Week 12
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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 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).
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Baseline, Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
January 30, 2009
First Posted (Estimate)
February 3, 2009
Study Record Updates
Last Update Posted (Estimate)
October 31, 2011
Last Update Submitted That Met QC Criteria
September 22, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Dermatologic Agents
- Micronutrients
- Anti-Bacterial Agents
- Leprostatic Agents
- Vitamins
- Keratolytic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Vitamin B Complex
- Antimalarials
- Folic Acid Antagonists
- Dapsone
- Nicotinic Acids
- Tazarotene
Other Study ID Numbers
- MA-ACZ0802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
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Nexgen Dermatologics, Inc.Unknown
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Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingModerate to Severe Acne VulgarisChina
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
Clinical Trials on Dapsone
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AllerganCompleted
-
AllerganWithdrawn
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Almirall, S.A.AllerganCompleted
-
Almirall, S.A.AllerganCompleted
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Almirall, S.A.AllerganCompletedAcne VulgarisUnited States, Canada
-
Almirall, S.A.AllerganCompletedAcne VulgarisUnited States, Canada
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Torrent Pharmaceuticals LimitedCatawba ResearchCompletedAcne VulgarisUnited States, Belize
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University Medicine GreifswaldCompletedMethemoglobinemia | Linear IgA Bullous DermatosisGermany
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Vanderbilt University Medical CenterTerminated
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Almirall, S.A.AllerganCompleted