NCT01597752

Biological Standardization of Blomia Tropicalis Allergen Extract

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the biologic activity of a Blomia tropicalis 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 Blomia tropicalis 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 Mites

Interventions

Type	Name	Description
BIOLOGICAL	Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control	Four concentrations of Blomia tropicalis 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: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-05-14
• Last updated: 2012-11-30

Locations

2 sites across 1 country: Spain