Bioequivalence of Ethylenediamine Dihydrochloride Study (NCT01798589) | Clinical Trial Compass
CompletedPhase 4
Bioequivalence of Ethylenediamine Dihydrochloride Study
United States16 participantsStarted 2012-07
Plain-language summary
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants With Positive Reactions to Ethylenediamine Dihydrochloride in MC (Methylcellulose) and Ethylenediamine Dihydrochloride in PVP (Polyvinylpyrrolidone)