NCT02527187

Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immune System Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-01
• Completion: 2016-11-01
• First posted: 2015-08-18
• Last updated: 2022-05-05
• Results posted: 2022-05-05

Locations

1 site across 1 country: Spain