Clinical trialNCT00243542CompletedPhase 4Interventional

Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency

SponsorAllerganEnrollment64Acne Vulgaris

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Steven Garrett, MS, DDS
QLT USA, Inc.
Study Director
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

29 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ACZONE Gel, 5%Vehicle

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2005
Primary completion: 31 Oct 2006
Completion: 31 Oct 2006
Last update posted: 30 May 2011
Registered enrollment: 64
Registry id: NCT00243542

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.