Determine the minimum amount of allergen from Dermatophagoides pteronyssinus and Dermatophagoides mite extract farinae that produces a positive skin reaction.

Phase 1

• Conditions: Allergy to mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae; MedDRA version: 18.0Level: LLTClassification code 10020419Term: House dust mite allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-005394-45-ES
• Lead Sponsor: Inmunotek, S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-10
• Study Completion: 2018-08-07
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

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 IGE.
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: The evaluation of the primary end point will be once the data base has been closed.;Main Objective: The main objective is to assess the concentration of extract allergen of Dermatophagoides pteronyssinus and Dermatophagoides farinae causing a papula of a size equivalent to that produced by a solution of dihidroclorhidrato of histamine to 10 mgml.;Secondary Objective: N/A;Primary end point(s): The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: Not applicable