Clinical Trial: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

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

Official Title: Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of PVP Formulations

Brief Summary: An open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens.

Detailed Summary: We are conducting an open, prospective, multi-center study to evaluate the bioequivalence of polyvinylpyrrolidone formulations of T.R.U.E. TEST fragrance mix and thimerosal allergens. Bioequivalence will be determined in 40 adult subjects, 20 per allergen, with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").
Sponsor: Allerderm

Current Primary Outcome: Bioequivalence between positive reactions to both fragrance mix and thimerosal each in PVP and HPC formulations. [ Time Frame: End of study. ]

Original Primary Outcome:

Current Secondary Outcome: Frequency of late/persistent reactions, irritation, tape reactions, subject self-report of itching or burning, and adverse events. [ Time Frame: End of study. ]

Original Secondary Outcome:

Information By: Allerderm

Dates:
Date Received: January 30, 2008
Date Started: January 2008
Date Completion:
Last Updated: February 19, 2013
Last Verified: May 2010