Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Overview

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.

Full Title of Study: “Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2009

Detailed Description

Primary endpoint: The performance (efficacy) of each allergen 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. Performance will be based on: – Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens. – Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens. Secondary endpoint: To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on: – The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period. – The frequency of adverse events and serious adverse events.

Interventions

  • Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens
    • 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.

Arms, Groups and Cohorts

  • Experimental: Sensitives
    • Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.
  • Experimental: Consecutives
    • Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen
  • Diagnostic Performance: Concordance
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen hydrocortisone-17-butyrate and the reference allergen
  • Diagnostic Performance: Concordance
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen methyldibromo-glutaronitrile and the reference allergen.
  • Diagnostic Performance: Concordance
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to TRUE Test allergen bacitracin and the reference allergen.
  • Diagnostic Performance: Concordance
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to TRUE Test allergen parthenolide and the reference allergen.
  • Diagnostic Performance: Concordance
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.
  • Diagnostic Performance: Concordance
    • Time Frame: Visit 5: 21 days after patch application
    • Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.
  • Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate
    • Time Frame: Visit 5: 21 days after patch application
    • Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
  • Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate
    • Time Frame: Visit 5: 21 days after patch application
    • The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
  • Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile
    • Time Frame: Visit 5: 21 days after patch application
    • The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
  • Diagnostic Performance: Sensitivity and Specificity: Bacitracin
    • Time Frame: Visit 5: 21 days after patch application
    • The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
  • Diagnostic Performance: Sensitivity and Specificity: Parthenolide
    • Time Frame: Visit 5: 21 days after patch application
    • The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
  • Diagnostic Performance: Sensitivity and Specificity: Disperse Blue
    • Time Frame: Visit 5: 21 days after patch application
    • The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
  • Diagnostic Performance: Sensitivity and Specificity: Bronopol
    • Time Frame: Visit 5: 21 days after patch application
    • The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Secondary Measures

  • Safety Evaluations: All T.R.U.E. Test Allergens
    • Time Frame: Day 2: 48 hours after application
    • Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.
  • Late Reactions: All T.R.U.E. Test Allergens
    • Time Frame: 7-10 days after patch application
    • Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).
  • Persistent Reactions: All T.R.U.E. Test Allergens
    • Time Frame: initially occur 2-4 days after application and last through 7-21days after patch application
    • Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Allerderm
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Evy Paulsen, M.D., Ph.D, Principal Investigator, Odense University Hospital
    • Joseph Fowler, MD, Principal Investigator, Dermatology Specialists PSC
    • Luz Fonacier, MD, Principal Investigator, Winthrop University
    • Donald V Belsito, MD, Principal Investigator, American Dermatology Associates
    • Jerri Hoskyn, MD, Principal Investigator, Rivery City Dermatology
    • Sandy Skotnicki-Grant, MD, Principal Investigator, Bay Dermatology Centre

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