Clinical Trial: Clinical Evaluation of T.R.U.E. TEST in Children and Adolescents

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

Official Title: Clinical Evaluation of T.R.U.E. TEST® Panel 1.1, 2.1 and 3.1: in Children and Adolescents

Brief Summary: An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents

Detailed Summary: An open, prospective,single-site, non-randomized study of the efficacy and safety of T.R.U.E. TEST Panel 1.1, 2.1 and 3.1 allergens in children and adolescents. After consent and enrollment, the timeline is as follows:A. T.R.U.E. TEST panels 1.1, 2.1 ,3.1 will be applied to the skin on the subject's back. All patch test panels will remain at the back until removed at the #2 Clinic Visit that occurs 2 days later. B. Skin reactions to all patch test panel allergens will be evaluated and scored shortly after panel removal.C. Skin reactions will be evaluated and scored again at either 3 or 4 days after #1 Clinic Visit. An additional follow-up visit (#3B Clinic Visit) may occur days after day 0 if needed to verify skin reactions.D. Skin reactions will be evaluated and scored again at the #4 Clinic Visit, which will occur 7 days +/- 2 days after #1 Clinic Visit (day 0). E. A follow up visit will take place approximately 3 weeks (21 + 2 days) after #1 Clinic Visit (day 0) to record any late or persistent reactions, and any adverse events. Investigators may elect to perform this evaluation via telephone if no reactions are present.
Sponsor: Allerderm

Current Primary Outcome:

  • Diagnostic Performance: Nickel Sulfate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4
  • Diagnostic Performance: Neomycin Sulfate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4
  • Diagnostic Performance: Wool Alcohol [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4
  • Diagnostic Performance: Potassium Dichromate [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4
  • Diagnostic Performance: Caine Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4
  • Diagnostic Performance: Fragrance Mix [ Time Frame: Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application ]
    Number of subjects with positive reactions recorded at visit 3 or visit 4
  • Diagnostic Performance: Coloph

    Original Primary Outcome: Frequency and characterization of positive reactions per allergen. [ Time Frame: 8 months ]

    Current Secondary Outcome:

    • Late Reactions [ Time Frame: 7-10 days after patch application ]
      Number of subjects who presented with late reactions
    • Persistent Reactions [ Time Frame: appear 2-4 days after patch application and last through 7-14 days after application ]
      Number of subjects who presented with persistent reactions
    • Irritation [ Time Frame: Visit 2: 48 hours after patch application ]
      Number of subjects who presented with irritation at patch removal
    • Adhesion [ Time Frame: Day 2: 48 hours after application ]
      Number of subjects who presented with poor adhesion at patch removal
    • Itching/Burning [ Time Frame: Day 2: 48 hours after patch application ]
      Number of subjects who presented with itching/burning at patch removal


    Original Secondary Outcome: Prevalence of late or persistent reactions, irritation, adhesion, subject-reported itching or burning, and adverse events [ Time Frame: 8 months ]

    Information By: Allerderm

    Dates:
    Date Received: November 20, 2008
    Date Started: November 2008
    Date Completion:
    Last Updated: December 19, 2013
    Last Verified: December 2013