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CompletedNCT02527122MM09Updated Aug 8, 2018

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

An interventional study of Allergen extracts in Immune System Diseases, sponsored by Inmunotek S.L.. Completed at 1 site in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Inmunotek S.L. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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..

Read the 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.

02

Conditions studied

  • Immune System Diseases

Keywords

  • Immune System Diseases
  • Prick Test
  • Dermatophagoides pteronyssinus
  • Dermatophagoides farinae
03

In context

Immune System Diseases

279 studies on the registry are indexed under Immune System Diseases; 81 are open to participants now.

This study's enrollment of 30 is below the median of 65 across 188 interventional studies indexed under Immune System Diseases.

Browse Immune System Diseases studies →

Lead sponsor

Inmunotek S.L. is the lead sponsor of 23 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testAllergen extracts
06

What researchers measure

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

    wheal size diameter OF THE SKIN PRICK TEST

    Time frame: 1 hour

07

Study locations

1 site
  • Hospital Univ. Ntra. Sra. de la Candelaria
    Sta. Cruz de Tenerife, Islas Canarias 38010,, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02527122
Lead sponsor
Inmunotek S.L.
Responsible party
Sponsor
First posted
Aug 18, 2015
Start date
Jul 21, 2016
Primary completion
Jul 2018
Completion
Aug 2018
Last update
Aug 8, 2018

Study contacts

Elena Rodríguez, MD
study director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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