CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 201 enrolled
Drug / intervention
10 HEP/mL Betula verrucosa allergen extract +3 morebiological
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/NCT02527187
NCT02527187Phase 2Completed

Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation.

Inmunotek S.L.·interventional·Posted Aug 18, 2015·Updated May 5, 2022

In Brief

A Phase 2 clinical trial evaluating 10 HEP/mL Betula verrucosa allergen extract, 25 HEP/mL Betula verrucosa allergen extract, and 2 other interventions for Immune System Diseases. Completed, enrolled 201 participants across 1 site.

Detailed Summary

The main objective is to evaluate the concentration of allergen extract of Betula verrucosa that elicit a papule equivalent to that produced by a solution of histamine dihydrochloride 10 mg / ml in size.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 18, 2015
Enrollment StartSep 1, 2015
Primary CompletionApr 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.9 years ago

Interventions

10 HEP/mL Betula verrucosa allergen extractbiological

The investigational product contained 10 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.

25 HEP/mL Betula verrucosa allergen extractbiological

The investigational product contained 25 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.

50 HEP/mL Betula verrucosa allergen extractbiological

The investigational product contained 50 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.

100 HEP/mL Betula verrucosa allergen extractbiological

The investigational product contained 100 HEP/mL Betula verrucosa allergen extract and was tested by administration onto skin. The test was carried out on the forearm following prick test technique.