NCT01740024

Biological Potency of the Cat Epithelial Allergenic Extracts

An Open-label, Multicentre Study Comparing the Biological Potency of the Native, Depigmented and Depigmented Polymerized Cat Epithelial Allergenic Extracts.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is to quantify the loss of in vivo biological potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the native allergenic extract (N).

Detailed description

This is an open-label, non-randomized phase II clinical trial. Three different concentrations of three different cat epithelial allergenic extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride and a glycerated phenol saline solution, respectively, will be tested in every subject on the volar surface of the forearm.

Conditions

• Cat Allergy (Disorder)

Interventions

Type	Name	Description
BIOLOGICAL	1 (Dose Response Skin Prick Tests)	3 different cat epithelium allergenic extracts at 3 different concentrations, 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: 2012-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-12-04
• Last updated: 2014-05-22

Locations

2 sites across 1 country: Spain