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Topical Rosemary Oil Application in Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Rosemary essential oil

Placebo

About this trial

This is an interventional treatment trial for Systemic Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ARCIM Institute
Universitätsklinikum Tuebingen, Abteilung Innere Medizin II

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Topical application of rosemary oil

Placebo

Arm Description

Rosemary essential oil (10% )

Pharmaceutical quality olive oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

"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).

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.

Full Information

NCT ID

NCT03531216

First Posted

May 9, 2018

Last Updated

January 8, 2019

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT03531216

Brief Title

Topical Rosemary Oil Application in Systemic Sclerosis

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

November 2, 2015 (Actual)

Primary Completion Date

March 21, 2016 (Actual)

Study Completion Date

March 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical application of rosemary oil

Arm Type

Active Comparator

Arm Description

Rosemary essential oil (10% )

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Pharmaceutical quality olive oil

Intervention Type

Other

Intervention Name(s)

Rosemary essential oil

Intervention Description

Topically-applied oil to both dorsal and palmar aspects of the hands

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Topically-applied oil to both dorsal and palmar aspects of the hands

Primary Outcome Measure Information:

Title

Change from baseline in temperature at the fingers

Description

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

Time Frame

baseline and 45 minutes after the intervention

Secondary Outcome Measure Information:

Title

Change from baseline in temperature at the back of the hands

Description

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

Time Frame

baseline and 45 minutes after the intervention

Title

Change from baseline in temperature at the forearms

Description

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

Time Frame

baseline and 45 minutes after the intervention

Title

Change from baseline of "Herdecke warmth perception questionnaire" (HeWEF)

Description

Patients' sense of warmth in different body regions as well as overall warmth assessed before and 45 minutes following the oil application

Time Frame

baseline and 45 minutes after the intervention

Title

"Scleroderma Health Assessment Questionnaire" (SHAQ)

Description

Time Frame

baseline

Title

Rodnan skin score of the hands

Description

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Vagedes, Dr.

Organizational Affiliation

ARCIM Institute; University of Tuebingen

Official's Role

Study Director

Facility Information:

Facility Name

ARCIM Institute

City

Filderstadt

State/Province

Baden Württemberg

ZIP/Postal Code

70794

Country

Germany

Facility Name

Universitätsklinikum Tuebingen, Abteilung Innere Medizin II

City

Tuebingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Topical Rosemary Oil Application in Systemic Sclerosis

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