Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Intervention: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Intervention description: Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2
Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dermatitis, Contact, Bronopol, Disperse Blue 106

Summary:

      We propose a prospective, multi-center, double-blind, randomized study comparing the
      diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue
      106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a
      clinical history of contact dermatitis and a positive patch test (current or previous) to the
      corresponding reference petrolatum allergen ("sensitives").
    

Eligibility criteria:

        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.