Topical Rosemary Oil Application in Systemic Sclerosis

ARCIM Institute Academic Research in Complementary and Integrative Medicine12 enrolled

Overview

The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.

In a crossover design, patients suffering from systemic sclerosis (12 subjects) receive applications of olive oil and of 10% Rosmarinus officinalis L. (rosemary) essential oil to both hands with a wash-out period of 3 hours. Effects on vasodilatation are measured with infrared thermography. Patients' sense of warmth is assessed by the "Herdecke warmth perception questionnaire". Measurements take place at baseline and 45 minutes following the interventions (pre-post-comparison). To determine within and between-differences, 2-sample t-tests will be used and effect sizes will be calculated (Standardized Effect Size).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Sclerosis

Interventions

Rosemary essential oilOTHER

Topically-applied oil to both dorsal and palmar aspects of the hands

PlaceboOTHER

Topically-applied oil to both dorsal and palmar aspects of the hands

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Systemic sclerosis with skin involvement of hands and fingers * Raynaud phenomenon with frequent symptoms of cold hands Exclusion Criteria: * Topical treatment with nitroglyceride * Lymphdrainage \< 24 hours * Other topical treatment of hands and arms \< 4 hours prior to study intervention

Locations (2)

ARCIM Institute

Filderstadt, Baden-Wurttemberg, Germany

Universitätsklinikum Tuebingen, Abteilung Innere Medizin II

Tübingen, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Change from baseline in temperature at the fingers

Distal skin temperature in °C measured at the fingers with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application

Time frame: baseline and 45 minutes after the intervention

Secondary Outcomes

Change from baseline in temperature at the back of the hands

Distal skin temperature in °C measured at the back of the hands with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application

Time frame: baseline and 45 minutes after the intervention

Change from baseline in temperature at the forearms

Distal skin temperature in °C measured at the forearms with a high-definition infrared camera (FLIR-Systems, type SC660) before and 45 minutes following the oil application

Time frame: baseline and 45 minutes after the intervention

Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)

Patients' sense of warmth in different body regions as well as overall warmth assessed before and 45 minutes following the oil application

Time frame: baseline and 45 minutes after the intervention

"Scleroderma Health Assessment Questionnaire" (SHAQ)

Questionnaire with 8 sections: e.g. dressing, arising, eating, walking,hygiene, etc... with 2 or 3 questions for each section. Scoring within each section is from0 (without any difficulty) to 3 (unable to do).

Time frame: baseline

Rodnan skin score of the hands

Skin score to assess the clinical severity of systemic scleroderma. 17 body areas are assessed by clinical palpation. The examiner assesses the skin thickness using a 4-point scale:0 = normal thickness, 1 = weak skin thickening, 2 = moderate skin thickening, 3 = severe skin thickening.

Data from ClinicalTrials.gov

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