NCT01798589

Bioequivalence of Ethylenediamine Dihydrochloride Study

Clinical Evaluation of TRUE Test Ethylenediamine Dihydrochloride Allergen: Bioequivalence of Vehicle Formulations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Allerderm · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.

Detailed description

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 minimum of 15 adult subjects, with a clinical history of contact dermatitis and a positive patch test (current or previous) to ethylenediamine ("sensitives").

Conditions

• Allergic Contact Dermatitis

Interventions

Type	Name	Description
DRUG	Ethylenediamine dihydrochloride allergen patch	1 allergen panel containing 2 allergen and 2 control patches

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2013-02-26
• Last updated: 2023-07-28
• Results posted: 2020-05-28

Locations

1 site across 1 country: United States