Clinical Evaluation of TRUE Test Ethylenediamine Dihydrochloride Allergen: Bioequivalence of Vehicle Formulations
Ethylenediamine dihydrochloride allergen patch
Dermatitis+6
+ Dermatitis, Contact
+ Hypersensitivity
Services Research Study
Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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").
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.16 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 10 years) to ethylenediamine dihydrochloride 18 years of age or older, otherwise in good health Female subjects of childbearing potential must consent to a urine pregnancy test; results must be negative for study inclusion. Informed consent signed and understood by each subject. Exclusion Criteria: Subjects unable to meet inclusion requirements Women who are breastfeeding or pregnant Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks Acute dermatitis outbreak or dermatitis on or near the test area on the back Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity) Subject participation in clinical trials of investigational drugs, treatments, or devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in this study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location