Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa (T502)
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|ClinicalTrials.gov Identifier: NCT02527187|
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Immune System Diseases||Biological: Betula verrucosa allergen extract||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extract Allergen From Betula Verrucosa. Test Sensitivity and Specificity of Diagnostic in Prick Test Preparation|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Betula verrucosa allergen extract
The investigational product contained the allergen extract of the pollen of Betula verrucosa and will be tested by administration onto skin. The test will be carried out on the forearm following prick test technique.
The allergen extract of the pollen of Betula verrucosa will be tested in four concentrations (100, 50, 25 and 10 HEP/mL).
Biological: Betula verrucosa allergen extract
Four concentrations of Betula verrucosa allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
- Papula size related with the equivalent produced by a solution of histamine dihydrochloride [ Time Frame: 1 hour ]Measuare the papula size of each of the four concentration of an allergen extract of Betula verrucosa, related with the equivalent produced by a solution of histamine dihydrochloride
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527187
|Hospital Lucus Augusti|
|Lugo, Galicia, Spain, 27003|
|Study Director:||Manuel Boquete, MD|