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Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa (T502)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02527187
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Immune System Diseases Biological: Betula verrucosa allergen extract Phase 2

Detailed Description:
Single open controlled study. The subjects will receive medication during 1 hour and will not need to be followed up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Positive clinical history or not of inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) from Betula verrucosa
  • Allergic subjects, must submit a prick-test positive (average of the papule > 3 mm diameter) with a summary of the same allergen I presence against the allergen specific Immunoglobulin E.
  • The average diameter of the papule obtained by histamine dihydrochloride to 10 mgml must be >3mm
  • Age: from 5 to 70 years.
  • They must be capable of giving informed consent

Exclusion Criteria:

  • Subjects outside of the age range.
  • Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the allergen from Betula extract verrucosa
  • Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated.
  • Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests.
  • Subjects treated with ss-blockers.
  • Unstable subjects of clinical point of view (asthma acute, febrile, etc).
  • Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives).
  • Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test.
  • Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
  • States of the subject that can not offer cooperation and severe psychiatric disorders.
  • Pregnant women at risk of pregnancy and breastfeeding women.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02527187

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Hospital Lucus Augusti
Lugo, Galicia, Spain, 27003
Sponsors and Collaborators
Inmunotek S.L.
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Study Director: Manuel Boquete, MD
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Responsible Party: Inmunotek S.L. Identifier: NCT02527187    
Other Study ID Numbers: T502-SSP-007
2013-005368-24 ( EudraCT Number )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Keywords provided by Inmunotek S.L.:
Immune System Diseases
Prick Test
Betula verrucosa
Additional relevant MeSH terms:
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Immune System Diseases