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Completed

NCT Number: NCT02527122

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

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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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Univ. Ntra. Sra. de la Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010,, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allergen extracts

Diagnostic Test

Primary outcomes

  1. 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

    Time frame: 1 hour

    wheal size diameter OF THE SKIN PRICK TEST

Sponsors and collaborators

Lead sponsor

Inmunotek S.L.

Industry

Registry information

Official study title

Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)

Acronym: MM09

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2015
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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