Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-21

Study Completion Date

2018-08-31

Brief Summary

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Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm..

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Detailed Description

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This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Conditions

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Immune System Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Allergen extracts

Skin prick test of 4 concentrations of D. pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of one forearm. Assessment of the wheal size after 15 minutes.

Skin prick test of 4 concentrations of D. farinae allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the other forearm. Assessment of the wheal size after 15 minutes.

Group Type EXPERIMENTAL

Allergen extracts

Intervention Type DIAGNOSTIC_TEST

Interventions

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Allergen extracts

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae.
* 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 area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2.
* Age: over 18 years of age.
* Both sexes.

Exclusion Criteria

* Subjects outside of the age range.
* Individuals 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 extract mixture of Dermatophagoides pteronyssinus or farinae.
* 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 in treatment 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 or women at risk of pregnancy and breastfeeding women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No