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Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02512653
Enrollment
33
Registered
2015-07-31
Start date
2015-11-30
Completion date
2016-01-31
Last updated
2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy to Tree Pollen

Keywords

Allergy to Cupressus pollen

Brief summary

Biological Standardization of Cupressus arizonica Allergen Extract.

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.

Interventions

BIOLOGICALCupressus arizonica

Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control

Sponsors

Laboratorios Leti, S.L.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Subject has provided written informed consent, appropriately signed and dated by subject. * Subject can be male or female of any race and ethinic group. * Age 18 years and 60 years ata the study inclusión day. * Positive clinical history of inhalatory allergy to Cupressus arizonica. * A positive prick test with a standarices commercially Cupressus arizonica allergen extract. * A positive prick test with positive control of histamine 10 mg/ml. * A positive test for specific IgE to Cupressus arizonica.

Exclusion criteria

* Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested. * Use of drugs that may interfere before and after with the skin reactions. * Treatment with certain drugs.

Design outcomes

Primary

MeasureTime frame
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phaseTest sites should be inspected and recorded 15-20 min after application

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026