Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
ACZ ACN 01. A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficient Subjects With Acne Vulgaris Treated With ACZONE™ (Dapsone) Gel, 5%.
1 other identifier
interventional
64
1 country
29
Brief Summary
The purpose of this study is to gather more information about the safety of ACZONE Gel, 5% in treating subjects with acne who have certain blood disorders. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2005
Shorter than P25 for phase_4
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2005
CompletedFirst Posted
Study publicly available on registry
October 24, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedMay 30, 2011
May 1, 2011
11 months
October 21, 2005
May 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The within-subject between treatment period differences in change from baseline to the 2nd week of each treatment period and change from baseline to the end of each treatment period will be summarized based upon various lab parameters.
The safety evaluable data set will be used, and each variable will be summarized using descriptive statistics.
Analyses of clinical lab values, AEs, vitals, and concomitant meds will be performed on all subjects who received treatment.
Secondary Outcomes (1)
Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
Interventions
Eligibility Criteria
You may qualify if:
- To be eligible for this study, subjects must fulfill all of the following criteria:
- Male or female ≥12 years of age.
- 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.
- A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal for the central reference laboratory.
You may not qualify if:
- Subjects meeting any of the following criteria will be excluded from the study:
- A dermal examination reveals the presence of severe cystic acne or acne conglobata.
- Treatment with isotretinoin (Accutane®) within 3 months of baseline and throughout the study.
- Subjects predisposed to anemia for other medical reasons, including but not limited to gastrointestinal bleeding and cancer.
- 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.
- Subjects who are using medication or eating foods that could potentially cause a hemolytic event in individuals with G6PD deficiency during the study.
- Facial surgery (dermabrasion, laser resurfacing or other facial cosmetic surgeries) within 3 months of baseline and throughout the study.
- A history of hypersensitivity to dapsone, parabens, or any component of the study products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (29)
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Department of Dermatology, University of California, San Francisco
San Francisco, California, 94115, United States
Dermatology Associates, PC at the Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Howard University Hospital Department of Dermatology
Washington D.C., District of Columbia, 20060, United States
FXM Research
Miami, Florida, 33175, United States
University Clinical Research, Inc
Pembroke Pines, Florida, 33024, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Boston Clinical Trials
Boston, Massachusetts, 02135, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202, United States
Washington University Dermatology Clinical Trials Unit
St Louis, Missouri, 63110, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Department of Dermatology SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Columbia University Medical Center Department of Dermatology
New York, New York, 10032, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Universtiy Dermatology Consultants, Inc.
Cincinnati, Ohio, 45219, United States
Paddington Testing Clinic
Philadelphia, Pennsylvania, 19103, United States
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107-6129, United States
Okatie Research Center, LLC
Beaufort, South Carolina, 29907', United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37917, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
DiscoveResearch, Inc.
Beaumont, Texas, 77701, United States
J&S Studies, Inc.
Bryan, Texas, 77802, United States
Research Across America
Dallas, Texas, 75234, United States
Suzanne Bruce and Associates, PA
Houston, Texas, 77056, United States
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
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.
PMID: 19075138DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Garrett, MS, DDS
QLT USA, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 21, 2005
First Posted
October 24, 2005
Study Start
November 1, 2005
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
May 30, 2011
Record last verified: 2011-05