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Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

NCT02527187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2022-05-05

Study results available
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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.

Conditions

  • Immune System Diseases

Interventions

BIOLOGICAL

10 HEP/mL Betula verrucosa allergen extract

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.

BIOLOGICAL

25 HEP/mL Betula verrucosa allergen extract

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.

BIOLOGICAL

50 HEP/mL Betula verrucosa allergen extract

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.

BIOLOGICAL

100 HEP/mL Betula verrucosa allergen extract

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.

Sponsors & Collaborators

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Manuel Boquete, MD

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527187 on ClinicalTrials.gov