NCT01984541

To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.

Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (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 biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (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. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines. Four concentrations of Artemisia vulgaris 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 Pollen

Interventions

Type	Name	Description
BIOLOGICAL	Artemisia vulgaris	Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-06-01
• Completion: 2014-09-01
• First posted: 2013-11-14
• Last updated: 2015-01-05

Locations

2 sites across 1 country: Spain