Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Intervention: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
Intervention description: Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP
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 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dermatitis, Contact

Summary:

      We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic
      performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate,
      Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse
      blue 106, and Bronopol.Allergen performance and safety 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.
    

Eligibility criteria:

        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).