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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Brono

Brief 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.

Detailed Summary:

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.

Sponsor: Allerderm

Current Primary Outcome:

  • Diagnostic Performance: Concordance [ Time Frame: Visit 5: 21 days after patch application ]
    Concordance: Number 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: Number 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: Number 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: Number 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: Number 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:Number of subjects who responded positively to T.R.U.E. Test allergen disperse blue and the reference allergen.


    • Original Primary Outcome: The performance of each allergen will be evaluated based on: Calculating concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens and calculated sensitivity and specificity. [ Time Frame: End of Study ]

    Current Secondary Outcome:

    • 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)


    Original Secondary Outcome: Evaluations will be based on: Frequency and characterization of late and/or persistent reactions, tape-induced irritation, incomplete panel adhesion, and subject-reported sensations of itching or burning and the frequency of adverse events. [ Time Frame: End of study ]

    Information By: Allerderm

    Dates:
    Date Received: March 3, 2008
    Date Started: April 2008
    Date Completion:
    Last Updated: November 18, 2015
    Last Verified: November 2015