Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency.
Information source: QLT Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: ACZONE Gel, 5% (Drug); Vehicle (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: QLT Inc Official(s) and/or principal investigator(s):
Steven Garrett, MS, DDS, Study Director, Affiliation: QLT USA, Inc.
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.
Clinical Details
Official title: 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%.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary outcome: 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 outcome: Acne Lesions: Tabular summaries of total lesion counts will be provided by appropriate descriptive statistics.
Detailed description:
Study Objectives:
- 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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
To be eligible for this study, subjects must fulfill all of the following 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:
Subjects meeting any of the following criteria will be excluded from the study:
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.
Locations and Contacts
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
Howard University Hospital Department of Dermatology, Washington, District of Columbia 20060, United States
Dermatology Associates, PC at the Washington Hospital Center, Washington, District of Columbia 20010, United States
University Clinical Research, Inc, Pembroke Pines, Florida 33024, United States
FXM Research, Miami, Florida 33175, 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
Columbia University Medical Center Department of Dermatology, New York, New York 10032, United States
Department of Dermatology SUNY Downstate Medical Center, Brooklyn, New York 11203, 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 Research Associates, Nashville, Tennessee 37203, United States
Dermatology Associates of Knoxville, Knoxville, Tennessee 37917, United States
Research Across America, Dallas, Texas 75234, United States
Suzanne Bruce and Associates, PA, Houston, Texas 77056, United States
DiscoveResearch, Inc., Beaumont, Texas 77701, United States
DermResearch, Inc., Austin, Texas 78759, United States
J&S Studies, Inc., Bryan, Texas 77802, United States
Virginia Clinical Research, Norfolk, Virginia 23507, United States
The Education and Research Foundation, Inc., Lynchburg, Virginia 24501, United States
Advanced Healthcare, SC, Milwaukee, Wisconsin 53209, United States
Additional Information
Starting date: October 2005
Ending date: October 2006
Last updated: April 21, 2006
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