This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Dermal Response Score
number of patients with a dermal response score of at least 2
Time frame: 21 days
Dermal Response and Effects Score
number of patients with a dermal response and effects score of at least 3
Time frame: 21 days
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