MedTrace Logo

Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

NCT01797562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-08-21

Study results available
· View outcomes & findings →

Summary

The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

Conditions

  • Allergic Contact Dermatitis

Interventions

DIAGNOSTIC_TEST

Panels 1.3, 2.2 and 3.2 experimental allergens

Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.

Sponsors & Collaborators

  • Allerderm

    lead INDUSTRY

Principal Investigators

  • Cory Dunnick, MD · Anschutz Health and Wellness Center, University of Colorado, Aurora, CO

  • Joseph Fowler, MD · Dermatology Specialists, Louisville, KY

  • Lawrence Eichenfield, MD · Rady Children's Hospital, San Diego

  • Patricia Norris, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-10
Primary Completion
2015-09-08
Completion
2015-09-08

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01797562 on ClinicalTrials.gov