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An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
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.
Details
| Lead sponsor | ParaPRO LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 65 |
| Start date | 2008-01 |
| Completion | 2008-02 |
Conditions
- Head Lice
Interventions
- NatrOVA Creme Rinse - 1%
- NatrOVA Creme Rinse Vehicle Only
- Blank Patch
Primary outcomes
- Visual grading of test site and assessments of adverse experiences — Evaluations over a 6 week period
Countries
United States