CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
TRUE Test allergens Fragrance Mix and Thimerosolbiological
Likely dose
TRUE Test allergens Fragrance Mix and Thimerosol 0.008 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/NCT00612768
NCT00612768Phase 2Completed
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Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens: Bioequivalence of Polyvinylpyrrolidone (PVP) Formulations

Allerderm·interventional·Posted Feb 12, 2008·Updated Apr 9, 2018

In Brief

A Phase 2 clinical trial evaluating TRUE Test allergens Fragrance Mix and Thimerosol for Dermatitis, Contact. Completed, enrolled 50 participants across 4 sites.

Detailed Summary

Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Contact
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2008
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.4 years ago

Interventions

TRUE Test allergens Fragrance Mix and Thimerosolbiological

* Thimerosal, 0.008 mg/cm2 in hydroxypropylcellulose * Thimerosal, 0.008 mg/cm2 in polyvinylpyrrolidone * Fragrance mix, 0.43 mg/cm2 in hydroxypropylcellulose with β-cyclodextrin * Fragrance mix, 0.43 mg/cm2 in polyvinylpyrrolidone with β-cyclodextrin Patches are placed at day one and removed 48 hours. The duration of the study lasts 21 days. However, the subject is only exposed the the study allergen for 48 hours.