Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

Primary endpoint:

To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test
allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and
a positive patch test to the respective reference allergen. Evaluations will include:

- Determination of the lowest concentration eliciting positive skin reactions (+1 or +2)
in 70-90% of sensitive subjects.

- Frequency of positive, negative, doubtful and irritant reactions for each allergen and
tested concentration.

- Concordance/discordance as compared to the corresponding reference petrolatum allergen.

Secondary endpoint:

To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult
subjects per allergen with a clinical history of contact dermatitis and a positive patch test
to the respective reference allergen. Evaluations will include:

- The frequency of tape-induced irritation at the test site, incomplete panel adhesion,
and subject-reported sensations of itching or burning.

- The frequency and characterization of adverse events and serious adverse events.

- The frequency and characterization of late and/or persistent reactions.

Inclusion Criteria:

- Current or previous symptoms and/or history consistent with allergic contact
dermatitis, and positive patch test (within the past 5 years) to Bronopol OR Current
or previous symptoms and/or history consistent with allergic contact dermatitis, and a
positive patch test (within the past 5 years) to Disperse blue 106 or Disperse blue
106/124 allergen mix.

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

- Premenopausal 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.