Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
NCT ID: NCT00243542
Last Updated: 2011-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2005-11-30
2006-10-31
Brief Summary
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ACZONE Gel, 5% is a prescription skin use (topical) medicine used to help treat acne in people 12 years and older. ACZONE Gel, 5% has been studied in approximately 4000 people and was shown to reduce the number of pimples and improve acne.
The active drug ingredient in ACZONE Gel, 5% is dapsone. People with blood disorders called "G6PD deficiency", "methemoglobin reductase deficiency", and "hemoglobin M" have a higher chance of side effects with dapsone.
G6PD is short for "glucose-6-phosphate dehydrogenase". It is an enzyme found in red blood cells, which carry oxygen to all parts of the body. G6PD helps the red blood cells to function normally. Some people have less G6PD in their red blood cells than the average person. This is called G6PD deficiency.
Two treatments - ACZONE Gel, 5% and placebo - will be studied for comparison.
Detailed Description
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* To compare the safety profile and risk of hemolysis of ACZONE Gel, 5% to that of the vehicle after 12 weeks each of twice daily applications in acne vulgaris subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
* To determine the systemic levels of plasma dapsone and N-acetyl dapsone during treatment with ACZONE Gel, 5%.
Study Population:
Approximately 60 male and female subjects
Study Treatment:
All subjects in the study will receive ACZONE Gel, 5% and vehicle in 1 of 2 sequences; each for a 12-week period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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ACZONE Gel, 5%
Vehicle
Eligibility Criteria
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Inclusion Criteria
1. Male or female ≥12 years of age.
2. A clear diagnosis of acne vulgaris, defined as ≥20 acne inflammatory and/or non-inflammatory lesions (≥10 of the acne lesions must be on the face, the others may be present on the neck, shoulders, upper chest, and upper back) at screening.
3. A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory.
Exclusion Criteria
1. A dermal examination reveals the presence of severe cystic acne or acne conglobata.
2. Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.
3. Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.
4. Subjects who are using topical or systemic medications for acne throughout the study. This includes, but is not limited to, benzoyl peroxide, antibiotics, topical Vitamin A derivatives such as Retin-A.
5. Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.
6. Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study.
7. A history of hypersensitivity to dapsone, parabens, or any component of the study products.
12 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Principal Investigators
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Steven Garrett, MS, DDS
Role: STUDY_DIRECTOR
QLT USA, Inc.
Locations
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Radiant Research, Inc.
Birmingham, Alabama, United States
Therapeutics Clinical Research
San Diego, California, United States
Department of Dermatology, University of California, San Francisco
San Francisco, California, United States
Dermatology Associates, PC at the Washington Hospital Center
Washington D.C., District of Columbia, United States
Howard University Hospital Department of Dermatology
Washington D.C., District of Columbia, United States
FXM Research
Miami, Florida, United States
University Clinical Research, Inc
Pembroke Pines, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, United States
Washington University Dermatology Clinical Trials Unit
St Louis, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Department of Dermatology SUNY Downstate Medical Center
Brooklyn, New York, United States
Columbia University Medical Center Department of Dermatology
New York, New York, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Universtiy Dermatology Consultants, Inc.
Cincinnati, Ohio, United States
Paddington Testing Clinic
Philadelphia, Pennsylvania, United States
Society Hill Dermatology
Philadelphia, Pennsylvania, United States
Okatie Research Center, LLC
Beaufort, South Carolina, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Dermatology Research Associates
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
DiscoveResearch, Inc.
Beaumont, Texas, United States
J&S Studies, Inc.
Bryan, Texas, United States
Research Across America
Dallas, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, United States
Countries
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References
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Piette WW, Taylor S, Pariser D, Jarratt M, Sheth P, Wilson D. Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. Arch Dermatol. 2008 Dec;144(12):1564-70. doi: 10.1001/archdermatol.2008.518.
Other Identifiers
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ACZ ACN 01
Identifier Type: -
Identifier Source: org_study_id