Brief Summary:
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:
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 Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis – a Prospective Crossover, Open-label, Nonrandomized Trial |
| Actual Study Start Date : | November 2, 2015 |
| Actual Primary Completion Date : | March 21, 2016 |
| Actual Study Completion Date : | March 21, 2016 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Topical application of rosemary oil
Rosemary essential oil (10% )
|
Other: Rosemary essential oil
Topically-applied oil to both dorsal and palmar aspects of the hands
|
| Placebo Comparator: Placebo
Pharmaceutical quality olive oil
|
Other: Placebo
Topically-applied oil to both dorsal and palmar aspects of the hands
|
Outcome Measures
Primary Outcome Measures :
- Change from baseline in temperature at the fingers [ Time Frame: baseline and 45 minutes after the intervention ]
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
Secondary Outcome Measures :
- Change from baseline in temperature at the back of the hands [ Time Frame: baseline and 45 minutes after the intervention ]
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
- Change from baseline in temperature at the forearms [ Time Frame: baseline and 45 minutes after the intervention ]
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
- Change from baseline of “Herdecke warmth perception questionnaire” (HeWEF) [ Time Frame: baseline and 45 minutes after the intervention ]
Patients’ sense of warmth in different body regions as well as overall warmth assessed before and 45 minutes following the oil application
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- https://drive.google.com/drive/folders/1-DfJyFRDLBuELif1aDICQPld4Ack8BRx?usp=sharing
- https://clinicaltrials.gov/ct2/show/NCT03531216
- The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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