Clinical Evaluation of Metal Panel Allergens: Dose Response Study
Condition: Dermatitis, Eczematous
MeSH terms: Dermatitis; Eczema
Intervention: Metal Allergen Epicutaneous Patch
Intervention description: 48 hour application of metal allergen patch to diagnose contact dermatitis
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      48-hour application of metal allergen patches to test for potential allergic responses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older.

          2. Past positive patch test result within the past 10 years (to one of the dilution
             series metals being tested on this study) or strong suspicion of metal contact allergy
             based on results of the Qualification Questionnaire.

          3. Unable to become pregnant or willing to use an acceptable method of contraception to
             prevent pregnancy if female of childbearing potential; (Inability to become pregnant
             includes all male subjects and female subjects who are postmenopausal for at least 1
             year, or surgically sterile- have had a hysterectomy, bilateral ovariectomy, uterine
             ablation or bilateral tubal ligation. Acceptable methods of contraception include: 1)
             systemic birth control; 2) double barrier method; 3) intrauterine device; 4)
             vasectomized partner; or 5) abstinence from sexual intercourse. Subject must agree to
             use acceptable contraception for the duration of the entire study.)

          4. Understands and signs the approved Informed Consent form which is consistent with all
             institutional, local and national regulations.

        Exclusion Criteria:

          1. Breastfeeding or pregnant (as determined by urine pregnancy test) or intending to
             become pregnant during the course of the study.

          2. Topical treatment with corticosteroids or other immunosuppressive agents on or near
             the test area during the 14 days prior to inclusion in this study.

          3. Systemic treatment with corticosteroids (equivalent to > 10 mg prednisone) or other
             immunosuppressive agents during the 14 days prior to inclusion in this study. Inhaled
             treatments are permitted. NOTE: Steroidal nose or eye drops 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. Conditions such as; fibromyalgia, chronic fatigue, depression, cognitive impairment,
             flu-like symptoms, diarrhea and/or headache without at least one of the symptoms
             related to metal exposure listed in Section 10.1 under physical examination

          7. 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).

          8. Participation in a clinical trial of an investigational drug, treatment or device
             during this study or 3 weeks prior to inclusion in this study.

          9. 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.