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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical application of rosemary oil | Active Comparator | Rosemary essential oil (10% ) |
|
| Placebo | Placebo Comparator | Pharmaceutical quality olive oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosemary essential oil | Other | Topically-applied oil to both dorsal and palmar aspects of the hands |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Vagedes, Dr. | ARCIM Institute; University of Tuebingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARCIM Institute | Filderstadt | Baden-Wurttemberg | 70794 | Germany | ||
| Universitätsklinikum Tuebingen, Abteilung Innere Medizin II |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Placebo | Other | Topically-applied oil to both dorsal and palmar aspects of the hands |
|
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 |
| Tübingen |
| Baden-Wurttemberg |
| 72076 |
| Germany |