Bioequivalence of Ethylenediamine Dihydrochloride Study

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

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

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").

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