Who is sponsoring NCT02474836?

NCT02474836 is sponsored by Roxall Medicina España S.A.

What condition does NCT02474836 study?

NCT02474836 studies Hypersensitivity.

What drugs are being tested in NCT02474836?

Interventions: Skin Prick Test - Atopic subjects, Skin Prick Test - Non Atopic subjects, Skin Prick Test - Allergic subjects.

What is the status of NCT02474836?

NCT02474836 is currently COMPLETED.

Last reviewed 2017-04-28 · How we verify

Biological Standardization of Artemisia Vulgaris and/or Platanus Acerifolia Pollen Extract and Dermatophagoides Farinae Mite Extract in Patients Sensitized to Them

NCT02474836 Phase 2 COMPLETED

Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the variability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are sensitized to the allergen concerned. The present study aims to standardize the allergen extracts of Artemisia vulgaris, Platanus acerifolia, Dermatophagoides farinae by using this method.

Details

Lead sponsor	Roxall Medicina España S.A
Phase	Phase 2
Status	COMPLETED
Enrolment	176
Start date	2012-11
Completion	2013-09

Conditions

Hypersensitivity

Interventions

Skin Prick Test - Atopic subjects
Skin Prick Test - Non Atopic subjects
Skin Prick Test - Allergic subjects

Primary outcomes

Wheal size area — 15 minutes after skin prick test
The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.

Countries

Spain