NCT02527122

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..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

July 21, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

August 17, 2015

Last Update Submit

August 7, 2018

Conditions

Immune System Diseases

Keywords

Immune System DiseasesPrick TestDermatophagoides pteronyssinusDermatophagoides farinae

Outcome Measures

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

    1 hour

Study Arms (1)

Allergen extracts

EXPERIMENTAL

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

Allergen extractsDIAGNOSTIC_TEST
Allergen extracts

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Univ. Ntra. Sra. de la Candelaria

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

Location

MeSH Terms

Conditions

Immune System Diseases

Study Officials

  • Elena Rodríguez, MD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 18, 2015

Study Start

July 21, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)