This is a Phase I single-site study to evaluate the irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to complete the study. The test articles will be applied to the upper back of the subjects during the study, and the placement of the test articles will be randomized. Abraded skin will be induced using sequential tape stripping.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
36
2% active gel
4% active gel
Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Cumulative Irritation Scores
the sum of the combined Dermal response and Other Effects Score
Time frame: 21 days
Time of combined Dermal response and Other Effects Score >=3
Total number of days with a combined Dermal Response and Other Effects score of 3 or more for each test article
Time frame: 21 days
Incidence of Test Article Discontunation
Number of subjects, by test article, where a test article was discontinued due to an unacceptable degree of irritation, or who experienced symptomatic intolerable irritation
Time frame: 21 days
Time to test article discontinuation
Number of days until sufficient irritation occurred to preclude repeat application to the same site, or who experienced symptomatic intolerable irritation
Time frame: 21 days
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Water for Injection, USP
matching placebo gel