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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Other: Rosemary essential oil; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden Württemberg
    • Filderstadt, Baden Württemberg, Germany, 70794
      • Arcim Institute
  • Baden-Württemberg
    • Tuebingen, Baden-Württemberg, Germany, 72076
      • Universitätsklinikum Tuebingen, Abteilung Innere Medizin II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: University Hospital Tuebingen
• Investigators: Study Director: Jan Vagedes, Dr., ARCIM Institute; University of Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2015
• Primary Completion (Actual): March 21, 2016
• Study Completion (Actual): March 21, 2016

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: ROS_02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No