Clinical Trial: Bioequivalence of Ethylenediamine Dihydrochloride Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of TRUE Test Ethylenediamine Dihydrochloride Allergen: Bioequivalence of Vehicle Formulations
Brief Summary: The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
Detailed Summary: We propose an open, prospective, single-site study to evaluate the bioequivalence of ethylenediamine dihydrochloride in methylcellulose (MC)and polyvinylpyrrolidone (PVP) formulations. Bioequivalence will be determined in 15 adult subjects, with a clinical history of contact dermatitis and a positive patch test (current or previous) to ethylenediamine ("sensitives").
Sponsor: Allerderm
Current Primary Outcome: Primary Endpoint- Concordance between positive reactions [ Time Frame: 21 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Secondary Endpoint-Safety of new vehicle formulations [ Time Frame: 21 days ]
Original Secondary Outcome: Same as current
Information By: Allerderm
Dates:
Date Received: February 20, 2013
Date Started: July 2012
Date Completion:
Last Updated: February 22, 2013
Last Verified: February 2013