Status:
COMPLETED
Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency
Lead Sponsor:
Allergan
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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 (...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00243542
Start Date
November 1 2005
End Date
October 1 2006
Last Update
May 30 2011
Active Locations (29)
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1
Radiant Research, Inc.
Birmingham, Alabama, United States, 35209
2
Therapeutics Clinical Research
San Diego, California, United States, 92123
3
Department of Dermatology, University of California, San Francisco
San Francisco, California, United States, 94115
4
Dermatology Associates, PC at the Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010