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Zeitschrift für Phytotherapie 2019; 40(02): 61-67
DOI: 10.1055/a-0736-5708
Forschung
© Georg Thieme Verlag KG Stuttgart · New York

Untersuchung der Hautverträglichkeit einer Schmerzcreme auf der Grundlage ätherischer Öle nach wiederholter Anwendung

Eine offene kontrollierte Studie an hautgesunden Probanden
Rainer Görne
Neustadt an der Weinstraße
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Publication History

Publication Date:
08 May 2019 (online)

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Zusammenfassung

Ziel der Studie war der Vergleich der Hautverträglichkeit einer Schmerzcreme mit den Wirkstoffen Eukalyptus-, Pfefferminz- und Rosmarinöl (EPR) gegenüber der Salbengrundlage sowie Natriumlaurylsulfat und einer Negativkontrolle. Insgesamt wurden 34 hautgesunde Probanden beiderlei Geschlechts (7 Männer, 27 Frauen, 18–75 Jahre) in die Studie aufgenommen. Nach wiederholter, okklusiver Applikation der Testprodukte über 21 Tage betrug die mittlere Summe des Irritationsscores 0,1 Punkte für die Negativkontrolle (NC), 0,2 Punkte für die Salbengrundlage (VC), 0,9 Punkte für die Schmerzcreme (EPR) und 11,0 Punkte für 0,05 % Natriumlaurylsulfat (SLS). Diese Ergebnisse wurden auch durch die Messungen des transepidermalen Wasserverlusts (TEWL) unterstützt. Die Unterschiede der TEWL-Werte nach 21 Tagen waren signifikant für VC gegenüber SLS (p < 0,0001) und für EPR gegenüber SLS (p < 0,0001), was die Schädigung der Hautbarrierefunktion durch SLS, nicht aber durch EPR zeigt.

Das mögliche Sensibilisierungspotenzial der Testformulierungen nach 21-tägiger okklusiver Applikation wurde unter Verwendung des Challenge-Patch-Tests nach einer Auswaschperiode von 2 Wochen bestimmt. 72 Stunden nach Applikation von EPR wurde lediglich bei einem von 34 Probanden ein schwaches Erythem beobachtet.

Somit zeigten die getestete Schmerzcreme und ihre Cremegrundlage ein sehr niedriges Potenzial für Hautreizungen und Schädigung der Hautbarrierefunktion bei 21-tägiger okklusiver Anwendung. Ferner traten im Verlauf der Studie keine weiteren behandlungsbedingten unerwünschten Ereignisse auf.

Abstract

Evaluation of the skin tolerance of a pain cream based on essential oils after repeated application: An open controlled study in skin healthy volunteers

The aim of the study was to compare the skin tolerance of a pain cream with the active ingredients eucalyptus, peppermint and rosemary oils (EPR) to the ointment base, sodium lauryl sulphate and a negative control. A total of 34 healthy subjects of both sexes (7 men, 27 women, age range 18 to 75 years) were included in the study. After repeated, occlusive application of the test products over 21 days, the mean sum of the irritation score was 0.1 points for the negative control (NC), 0.2 points for the ointment base (VC), 0.9 points for the pain cream (EPR), and 11.0 points for 0.05 % sodium lauryl sulphate (SLS). These results were also supported by measurements of transepidermal water loss (TEWL). The differences in the TEWL values after 21 days were significant for VC versus SLS (p < 0.0001) and for EPR versus SLS (p < 0.0001), indicating damage of the skin barrier function by SLS, but not by EPR.

The possible sensitization potential of the test formulations after 21 days of occlusive application was determined using the challenge patch test after a washout period of two weeks. Seventy-two hours after application of EPR, only one out of 34 subjects experienced mild erythema.

Summarizing the tested pain cream and its cream base showed a very low potential for skin irritation and damage of the skin barrier function after 21 days of occlusive application. Furthermore, no further treatment-related adverse events occurred during the study.

Schlüsselwörter

Pflanzliche Schmerzcreme - Eukalyptusöl - Pfefferminzöl - Rosmarinöl - Monoterpene - Irritationsscore - Sensibilisierung

Key words

Herbal pain-relief ointment - eucalyptus - peppermint - essential oils - monoterpenes - irritation score - sensitization
 

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