Acne Vulgaris Clinical Trial
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%.
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 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-6-phosphate-dehydrogenase (G6PD) deficiency.
- To determine the systemic levels of plasma dapsone and N-acetyl dapsone during
treatment with ACZONE Gel, 5%.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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