CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 116 enrolled
Drug / intervention
Panels 1.3, 2.2 and 3.2 experimental allergensother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01797562
NCT01797562N/ACompleted
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Clinical Evaluation of T.R.U.E. Test Panel 3.2 in Children and Adolescents (PREA II)

Allerderm·interventional·Posted Feb 22, 2013·Updated Aug 21, 2020

In Brief

A clinical study evaluating Panels 1.3, 2.2 and 3.2 experimental allergens for Allergic Contact Dermatitis. Completed, enrolled 116 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Contact Dermatitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2013
Enrollment StartDec 10, 2012
Primary CompletionSep 8, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.4 years ago

Interventions

Panels 1.3, 2.2 and 3.2 experimental allergensother

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.