NCT00605956

NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: ParaPRO LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Head Lice

Interventions

Type	Name	Description
DRUG	NatrOVA Creme Rinse - 1%	NatrOVA Creme Rinse - 1% spinosad
DRUG	NatrOVA Creme Rinse Vehicle Only	NatrOVA Creme Rinse Vehicle - no spinosad
DRUG	Blank Patch	Blank Patch

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-02-01
• Last updated: 2008-08-04

Locations

1 site across 1 country: United States