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Topical Rosemary Oil Application in Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT03531216
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Other: Rosemary essential oil Other: Placebo Not Applicable

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. "Scleroderma Health Assessment Questionnaire" (SHAQ) [ Time Frame: baseline ]
    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).

  5. Rodnan skin score of the hands [ Time Frame: baseline ]
    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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531216


Locations
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Germany
ARCIM Institute
Filderstadt, Baden Württemberg, Germany, 70794
Universitätsklinikum Tuebingen, Abteilung Innere Medizin II
Tuebingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
University Hospital Tuebingen
Investigators
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Study Director: Jan Vagedes, Dr. ARCIM Institute; University of Tuebingen

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Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT03531216     History of Changes
Other Study ID Numbers: ROS_02
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases