Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Primary endpoint:

The performance (efficacy) of each allergen will be evaluated in adult patients with
suspected contact dermatitis, and in adult patients with a known or suspected sensitization
to at least one of the seven allergens. Performance will be based on:

- Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their
corresponding petrolatum or aqueous-based allergens.

- Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate,
Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse
blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"),
and/or in adult subjects with a clinical history of contact dermatitis and a current or
previous positive patch test to one (or more) of these 7 allergens ("sensitives").
Evaluations will be based on:

- The frequency and characterization of late and/or persistent reactions, tape-induced
irritation at the test site, incomplete panel adhesion, and subject-reported sensations
of itching or burning during the test period.

- The frequency of adverse events and serious adverse events.

Inclusion Criteria:

- Consecutive subjects must report symptoms and/or history consistent with allergic
contact dermatitis to at least one of the allergens tested in the study (i.e.,
subjects are visiting the clinic/physician to diagnose, treat or resolve this
condition).

- Sensitive subjects must have a positive patch test to one of the following allergens
within the past 10 years.

- Gold sodium thiosulfate

- Methyldibromoglutaronitrile (alone or with phenoxyethanol)

- Bacitracin

- Bronopol

- Disperse blue 106 (alone or with Disperse blue 124)

- Parthenolide (or Compositae mix)

- Hydrocortisone-17-butyrate

- All subjects must be adults over 18 years of age, and otherwise in good health.

- Premenopausal female subjects with childbearing potential must consent to a urine
pregnancy test; urine 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 corticosteroid treatment during the last 7 days before visit 1 on or near the
test area.

- Systemic treatment with corticosteroids or other immunosuppressants during the last 7
days.before visit 1.

- Subjects currently receiving (or received in the 21 days before visit 1) other
investigational drugs, treatments or devices, or participating in another clinical
study.

- Treatment with ultraviolet (UV) light (including tanning) during the 21 days before
visit

- 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).