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

Study Identifier
ACZ ACN 01
CT.gov Identifier
NCT00243542
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Dermatology - Acne
    • Study Drug
  • ACZONE Gel, 5%
  • Vehicle
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Radiant Research, Inc.
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    Therapeutics Clinical Research
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Department of Dermatology, University of California, San Francisco
    San Francisco, California, United States, 94115
    Status
    Not applicable
    Location
    Dermatology Associates, PC at the Washington Hospital Center
    Washington D.C., District of Columbia, United States, 20010
    Status
    Not applicable
    Location
    Howard University Hospital Department of Dermatology
    Washington D.C., District of Columbia, United States, 20060
    Status
    Not applicable
    Location
    FXM Research
    Miami, Florida, United States, 33175
    Status
    Not applicable
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