Bioequivalence of Ethylenediamine Dihydrochloride Study

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allerderm

Criteria

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