Irritation/Irritant Clinical Trial
Official title:
Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites
The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects.
This Cumulative Irritation Evaluation is designed to determine the skin irritation potential
of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy
human subjects. Abraded skin will be challenged because the Test Product may be used, in
practice, on non-intact skin. The primary research objective in this study is determine the
skin irritation potential of RUT058-60. This question will be answered based on the observed
results acquired evaluating its application to the abraded and non-abraded skin of at least
30 volunteer subjects, on the test product relative to the control readings.
A sufficient number of subjects will be recruited into the study to ensure 30 subjects,
including both males and females, complete the study. Prior to the first application of test
materials, designated skin sites will be abraded using the Tape Stripping Procedure.
Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive
Control and Negative Control to abraded and non-abraded sites on the skin in the scapular
region of each subject's back. The irritation potential of the test materials will be
determined over the course of a 21-day challenge period on at least 30 subjects. A test
material will be applied to the same site, abraded and non-abraded, on each day for 21 days.
The six skin sites will be evaluated visually prior to each patch application and following
the final patch removal.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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