Topical Rosemary Oil Application in Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: Rosemary essential oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical application of rosemary oil<br>Rosemary essential oil (10% ) | Other: Rosemary essential oil<br>* Topically-applied oil to both dorsal and palmar aspects of the hands<br>|
| Placebo Comparator: Placebo<br>Pharmaceutical quality olive oil | Other: Placebo<br>* Topically-applied oil to both dorsal and palmar aspects of the hands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and 45 minutes after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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). | 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. | baseline |