Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Intervention: Ammoniated mercury; Aluminum chloride and aluminum lactate; Sodium tetrachloropalladate
Intervention description: Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.; Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.; Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Biologic
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Patch Test; Allergy Testing; Contact Dermatitis; Mercury, Aluminum or Palladium skin allergy

Summary:

      The purpose of this study is to evaluate the diagnostic performance and safety of ascending
      doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal
      allergen panel. Optimal dose will be selected based on the lowest dose of each allergen
      eliciting a positive response in 70-90% of subjects tested.
    

Eligibility criteria:

        Inclusion Criteria:

        1.15 years of age or older.

        2. History of contact dermatitis.

        3. Positive patch results to 1) mercury (elemental), 2) aluminum (aluminum chloride
        hexahydrate, aluminum hydroxide and/or aluminum lactate) or 3) palladium (sodium
        tetrachloropalladate and/or palladium chloride) within the past 10 years.

        4. Male or non-pregnant non-lactating female. Female subjects must state, at visit one that
        they are not pregnant, not lactating nor are they intending to become pregnant for the
        course of the study.

        5. Has understood and signed the approved Informed Consent/Assent Form, which is consistent
        with all institutional, local and national regulations. Assent Form for all minor subjects
        (ages 15-17) must be signed by the guardian/parent.

        Exclusion Criteria:

          1. Breastfeeding or pregnant or intending to become pregnant for the course of the study.

          2. Topical treatment with corticosteroids or other immunosuppressive agents on or near
             the test area during the 7 days prior to inclusion in this study.

          3. Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other
             immunosuppressive agents during the 7 days prior to inclusion in this study. Inhaled
             treatments are permitted.

          4. Treatment with ultraviolet (UV) light (including tanning) during the 3 weeks prior to
             inclusion in this study.

          5. Acute dermatitis outbreak or dermatitis on or near the test area on the back.

          6. Inability 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).

          7. Participation in a clinical trial of an investigational drug, treatment or device
             other than T.R.U.E. TEST during this study or 3 weeks prior to inclusion in this
             study.

          8. An opinion of the Investigator that deems the potential subject to be non-compliant,
             unable to return for study visits or complete the study as detailed in the protocol.