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Completed

NCT Number: NCT03531216

Topical Rosemary Oil Application in Systemic Sclerosis

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ARCIM Institute, Filderstadt, Baden-Wurttemberg, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosemary essential oil

Other

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

Placebo

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 21, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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