Trials Sponsors Conditions Drugs Pricing

Conditions

Allergy to Alternaria Fungus

Keywords

ImmunotherapySkin prick testStandardizationAlternaria alternata

Outcome Measures

Primary Outcomes (1)

Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Test sited chould be inspected and recorded 15-20 min after appliction

Study Arms (1)

Prick Test

EXPERIMENTAL

Alternaria alternata allergen extract Positve control Negative control

Biological: four differente concentrations of Alternaria alternata allergen extract, positive control and negative control

Interventions

four differente concentrations of Alternaria alternata allergen extract, positive control and negative controlBiological

This concentrations will be tested in every patient in duplicate on the volar surface of the forearm.

Also known as: Four concentratios of Alternaria alternata together with a positive and negative control.

Prick Test

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 59 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Positive clinical history of inhalatory allergy to Alternaria alternata. Subject has provided written informed consent, appropriately signed and dated by the subject.
The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ≥ 3 mm.

Sponsors & Collaborators

Laboratorios Leti, S.L.
Industrylead

Study Sites (2)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Hospital Clínico Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Study Officials

Lena Erbiti
Laboratorios Leti, S.L.U
STUDY CHAIR
Santiago Quirce, MD
Hospital Universitario La Paz
PRINCIPAL INVESTIGATOR
José Damian López, MD
HOSPITAL CLÍNICO UNIVERSITARIO VIRGEN DE LA
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 14, 2013

Study Start

February 2014

Date type not reported

This date has not been verified as actual or estimated.

To Determine the Minimum Amount of Alternaria Alternata Allergen Extract Producing a Positive Skin Reaction.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Prick Test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Prick Test

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations