NCT01984528

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

Biological Standardization of Alternaria Alternata 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 – 59 Years
• Healthy volunteers: Not accepted

Summary

The objetive of this study is to determine the minimum amount of Alternaria alternata allergen extract producing in a positive skin reaction.

Detailed description

This is an open, unblinded and non-randomized biological assay. The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.

Conditions

• Allergy to Alternaria Fungus

Interventions

Type	Name	Description
BIOLOGICAL	four differente concentrations of Alternaria alternata allergen extract, positive control and negative control	This concentrations will be tested in every patient in duplicate on the volar surface of the forearm.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2013-11-14
• Last updated: 2015-01-05

Locations

2 sites across 1 country: Spain