Clinical Trial: NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: ParaPRO LLC

Current Primary Outcome: Visual grading of test site and assessments of adverse experiences [ Time Frame: Evaluations over a 6 week period ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ParaPRO LLC

Dates:
Date Received: January 21, 2008
Date Started: January 2008
Date Completion:
Last Updated: July 31, 2008
Last Verified: May 2008