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 ]

Bioequivalence will be based on concordance (or agreement) between positive reactions to ethylenediamine dihydrochloride in MC and in PVP formulations.


Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary Endpoint-Safety of new vehicle formulations [ Time Frame: 21 days ]

To evaluate the safety of the new vehicle formulations in adult subjects with known contact dermatitis ("sensitives") as demonstrated by a current or previous positive patch test to one (or more) of these allergens ("sensitives").


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