Conditions: Allergic Contact Dermatitis
Keywords: ethylenediamine dihydrochloride
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief 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").

Arms:
arm 1: Ethylenediamine dihydrochloride in methylcellulose 50 mcg/cm2 Ethylenediamine dihydrochloride in polyvinylpyrrolidone 50 mcg/cm2 Methylcellulose (negative control 1) Polyvinylpyrrolidone (negative control 2)

Interventions: intervention 1: Ethylenediamine dihydrochloride allergen patch
Intervention descriptions: intervention 1: 1 allergen panel containing 2 allergen and 2 control patches

Protocol document: