Lead Sponsor

Allerderm

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

•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.

•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