Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations

Bioequivalence will be determined in 40 adult subjects (20 per allergen), who have a clinical
history of contact dermatitis and have tested positive to fragrance mix or thimerosal.

Inclusion Criteria:

- Current or previous symptoms and/or history consistent with allergic contact
dermatitis, and positive patch test (within the past 5 years) to fragrance mix AND/OR
thimerosal.

- All subjects must be adults (18 years of age or older) and otherwise in good health.

- Pre-menopausal female subjects must consent to a urine pregnancy test; results must be
negative for study inclusion.

- Informed consent must be signed and understood by each subject, and consistent with
all institutional, local and national regulations.

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.