Topical Rosemary Oil Application in Systemic Sclerosis
Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2016
CompletedFirst Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedJanuary 10, 2019
May 1, 2018
5 months
May 9, 2018
January 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change from baseline in temperature at the back of the hands
baseline and 45 minutes after the intervention
Change from baseline in temperature at the forearms
baseline and 45 minutes after the intervention
Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)
baseline and 45 minutes after the intervention
"Scleroderma Health Assessment Questionnaire" (SHAQ)
baseline
Rodnan skin score of the hands
baseline
Study Arms (2)
Topical application of rosemary oil
ACTIVE COMPARATORRosemary essential oil (10% )
Placebo
PLACEBO COMPARATORPharmaceutical quality olive oil
Interventions
Topically-applied oil to both dorsal and palmar aspects of the hands
Eligibility Criteria
You may qualify if:
- Systemic sclerosis with skin involvement of hands and fingers
- Raynaud phenomenon with frequent symptoms of cold hands
You may not qualify if:
- Topical treatment with nitroglyceride
- Lymphdrainage \< 24 hours
- Other topical treatment of hands and arms \< 4 hours prior to study intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
ARCIM Institute
Filderstadt, Baden-Wurttemberg, 70794, Germany
Universitätsklinikum Tuebingen, Abteilung Innere Medizin II
Tübingen, Baden-Wurttemberg, 72076, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan Vagedes, Dr.
ARCIM Institute; University of Tuebingen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2018
First Posted
May 21, 2018
Study Start
November 2, 2015
Primary Completion
March 21, 2016
Study Completion
March 21, 2016
Last Updated
January 10, 2019
Record last verified: 2018-05