NCT01675349

Biological Standardization of Chenopodium Album Allergen Extract

Biological Standardization of Chenopodium Album Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the biologic activity of a Chenopodium album allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

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. Four concentrations of Chenopodium album 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 forearm.

Conditions

• Allergy to Chenopodium Album

Interventions

Type	Name	Description
BIOLOGICAL	Prick test Chenopodium album allergen extract	This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Chenopodium album 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 forearm. This test will be referred to as the Titrated Skin Prick test.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-08-29
• Last updated: 2014-05-23

Locations

2 sites across 1 country: Spain