Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.
The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
NatrOVA Creme Rinse - 1% spinosad
NatrOVA Creme Rinse Vehicle - no spinosad
Blank Patch
Hill Top Research
St. Petersburg, Florida, United States
Visual grading of test site and assessments of adverse experiences
Time frame: Evaluations over a 6 week period
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