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Sponsored by: |
Allergan |
Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00243542 |
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.
Condition | Intervention | Phase |
Acne Vulgaris |
Drug: ACZONE Gel, 5% Drug: Vehicle |
Phase IV |
Genetics Home Reference related topics: | glucose-6-phosphate dehydrogenase deficiency |
MedlinePlus related topics: | Acne |
ChemIDplus related topics: | Dapsone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study |
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%. |
Estimated Enrollment: | 60 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2006 |
Study Objectives:
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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for this study, subjects must fulfill all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
Show 29 Study Locations |
Allergan |
Study Director: | Steven Garrett, MS, DDS | QLT USA, Inc. |
Study ID Numbers: | ACZ ACN 01 |
First Received: | October 21, 2005 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00243542 |
Health Authority: | United States: Food and Drug Administration |
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