Bioequivalence of Ethylenediamine Dihydrochloride Study

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 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