CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
T.R.U.E. TEST® Skin Patch Test: Dose Response Allergensbiological
Likely dose
T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens 0.15 mgfrom 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/NCT00640250
NCT00640250Phase 2Completed
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Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study

Allerderm·interventional·Posted Mar 21, 2008·Updated Apr 9, 2018

In Brief

A Phase 2 clinical trial evaluating T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens for Contact Dermatitis. Completed, enrolled 48 participants across 2 sites in 2 countries.

Detailed Summary

We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 subjects per allergen) with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen ("sensitives").

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContact Dermatitis
CountriesDenmark, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.3 years ago

Interventions

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergensbiological

Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2 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.