Topical Rosemary Oil Application in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531216
• Other study ID #: ROS_02
• Status: Completed
• Phase: N/A
• Start date: November 2, 2015
• Est. completion date: March 21, 2016

Study information

• Verified date: May 2018
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 21, 2016
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Rosemary essential oil
Topically-applied oil to both dorsal and palmar aspects of the hands
• Placebo
Topically-applied oil to both dorsal and palmar aspects of the hands

Locations

Country	Name	City	State
Germany	ARCIM Institute	Filderstadt	Baden Württemberg
Germany	Universitätsklinikum Tuebingen, Abteilung Innere Medizin II	Tuebingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	"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
Secondary	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