Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

Phase 2

Completed

• Conditions: Immune System Diseases

• Registration Number: NCT02527187
• Lead Sponsor: Inmunotek S.L.

Brief 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.

Detailed Description

Open, prospective, unblinded and non-randomized biological assay. Each patient was tested with four concentrations of allergen and with a histamine and saline solution as positive and negative controls, respectively.

Study Timeline

• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Study Start: 2015-09
• Primary Completion: 2016-04
• Study Completion: 2016-11
• Results First Submitted: 2020-06-10
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Results First Posted: 2022-05-05
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Specificity for 50 HEP/mL	1 hour	Specificity for 50 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of negatives that are correctly identified by the test.; Specificity: True negatives/Total no disease.
Sensitivity for 100 HEP/mL	1 hour	Sensitivity for 100 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of positives that are correctly identified by the test.; Sensitivity: True positives/Total disease
Sensitivity for 25 HEP/mL	1 hour	Sensitivity for 25 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of positives that are correctly identified by the test.; Sensitivity: True positives/Total disease
Sensitivity for 10 HEP/mL	1 hour	Sensitivity for 10 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of positives that are correctly identified by the test.; Sensitivity: True positives/Total disease
Sensitivity for 50 HEP/mL	1 hour	Sensitivity for 50 HEP/mL concentration of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of positives that are correctly identified by the test.; Sensitivity: True positives/Total disease
Specificity for 100 HEP/mL	1 hour	Specificity for 100 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of negatives that are correctly identified by the test.; Specificity: True negatives/Total no disease.
Specificity for 25 HEP/mL	1 hour	Specificity for 25 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of negatives that are correctly identified by the test.; Specificity: True negatives/Total no disease.
Specificity for 10 HEP/mL	1 hour	Specificity for 10 HEP/mL concentrations of the pollen of Betula verrucosa allergen extract used in skin prick test.; It is the proportion of negatives that are correctly identified by the test.; Specificity: True negatives/Total no disease.

Trial Locations

Locations (1)

Hospital Lucus Augusti; 🇪🇸 Lugo, Galicia, Spain