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

Completed · Phase 4

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00243542

Run by

Allergan

People needed

64

Starts

2005-11-01

Expected to finish

2006-10-01

Last updated by the study team

2011-05-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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