Allergies
Conditions
Brief summary
The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint
Detailed description
To determine the in vitro biological potency expressed as HEP (1 HEP = 10,000 biological units) of the concentration of the investigational product that elicits a wheal of a size equivalent to that produced by a solution of histamine dihydrochloride at 10 mg/ml., Safety assessment through descriptive analysis of adverse reactions that may occur during the course of the study.
Interventions
DRUGLepidoglyphus destructor skin-prick test
DRUGHistamine dihydrochloride skin-prick test
DRUGDermatophagoides pteronyssinus skin-prick test
DRUGDermatophagoides farinae skin-prick test
DRUGBlomia tropicalis skin-prick test
Sponsors
Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the in vitro biological potency expressed as HEP (1 HEP = 10,000 biological units) of the concentration of the investigational product that elicits a wheal of a size equivalent to that produced by a solution of histamine dihydrochloride at 10 mg/ml., Safety assessment through descriptive analysis of adverse reactions that may occur during the course of the study. | — |
Countries
Spain
Outcome results
None listed