Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 29 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts (MM09)

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.
ClinicalTrials.gov Identifier: NCT02527122
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Inmunotek S.L.

Brief Summary:
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..

Condition or disease Intervention/treatment Phase
Immune System Diseases Diagnostic Test: Allergen extracts Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)
Actual Study Start Date : July 21, 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Diagnostic Test: Allergen extracts



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02527122


Locations
Layout table for location information
Spain
Hospital Univ. Ntra. Sra. de la Candelaria
Sta. Cruz de Tenerife, Islas Canarias, Spain, 38010,
Sponsors and Collaborators
Inmunotek S.L.
Investigators
Layout table for investigator information
Study Director: Elena Rodríguez, MD

Layout table for additonal information
Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT02527122     History of Changes
Other Study ID Numbers: MM09-STD-011
2013-005394-45 ( EudraCT Number )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inmunotek S.L.:
Immune System Diseases
Prick Test
Dermatophagoides pteronyssinus
Dermatophagoides farinae

Additional relevant MeSH terms:
Layout table for MeSH terms
Immune System Diseases
Histamine
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs