Topical therapy with the betulin based triterpene extract (TE) in patients with chronic pruritus

MN Laszczyk; NQ Phan; D Siepmann; M Augustin; TA Luger; S Ständer

doi:10.1055/s-0029-1234780

Planta Medica, Table of Contents

Topical therapy with the betulin based triterpene extract (TE) in patients with chronic pruritus

MN Laszczyk ¹, NQ Phan ², D Siepmann ², M Augustin ³, TA Luger ², S Ständer ²

¹Birken GmbH, Department for Research and Development; Streiflingsweg 11, 75223 Niefern-Öschelbronn, Germany
² Competence Centre for Pruritus, Department of Dermatology, University Clinics Münster; Von Esram Str. 58, 48149Münster, Germany
³CV Derm, Department for Dermatology and Venerology, University Hospital Eppendorf, Martinistraße 58, 20246 Hamburg, Germany

Abstract

The betulin (BE) based triterpene extract (TE) from birch cork contains 81% BE, betulinic acid (4%), lupeol (3%), erythrodiol (1%) and oleanolic acid (1%). The TE is able to stabilize a W/O emulsion (BE emulsion) of water and jojoba oil without any other additives [1]. Experimental studies suggest that the TE components induce anti-inflammatory [2] and wound healing effects [3] in the skin, but no antipruritic activity is published, yet.

An open-labelled trial aimed to investigate the antipruritic effects of the BE emulsion. 23 patients with chronic pruritus on unchanged skin as well as 20 patients with pruritus and chronic scratch lesions received the BE emulsion. It was applied for a period of two weeks twice daily on the affected areas followed by 2 weeks without cream and a follow-up visit. Before and after therapy, patients received a detailed clinical investigation with documentation of present scratch lesions assessed by the prurigo-score. For daily documentation of pruritus intensity patients used the visual analogue scale (VAS) from 0 to 10. Statistical analysis was done by intention-to-treat analysis. A significant antipruritic effect was documented in 56.2% of patients of group 1 and 70.0% of patients of group 2. The dynamic score (reduction of pruritus intensity in percent) in responsive patients was 66.8% in group 1 and 82.7% in group 2. The analysis of the VAS data before and after therapy showed a 2.6-fold better response of group 2. Patients of group 2 showed a slight regression of scratch lesions within two weeks of cream application. Nearly all patients (95.3%) tolerated the therapy well.

The present results suggest that the topical use of TE within a BE emulsion is an effective, adjuvant antipruritic treatment option with good compatibility in patients with chronic pruritus, especially in patients with chronic scratch lesions.

References: [1] Daniels, R. (2008) Pharm. Ztg. 11:34–35.

[2] Alakurtti, S. (2006) Eur. J. Pharm. Sci. 29:1–13.

[3] Harish, B.G. (2008) Phytomedicine 15:763–767.