CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 235 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 0.020 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/NCT00640614
NCT00640614Phase 3Completed
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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 Bronopol

Allerderm·interventional·Posted Mar 21, 2008·Updated May 5, 2020

In Brief

A Phase 3 clinical trial evaluating T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens for Contact Dermatitis. Completed, enrolled 235 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago

Interventions

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

Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP 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.