Status:
COMPLETED
Bioequivalence of Ethylenediamine Dihydrochloride Study
Lead Sponsor:
Allerderm
Conditions:
Allergic Contact Dermatitis
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01798589
Start Date
July 1 2012
End Date
August 1 2012
Last Update
July 28 2023
Active Locations (1)
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1
Dermatology Specialists PSC
Louisville, Kentucky, United States, 40202