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Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators

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ClinicalTrials.gov Identifier: NCT03761199
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University School of Physical Education, Krakow, Poland

Brief Summary:
The aim of the planned study will be to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of patients with atopic dermatitis (AD). The aim of the study will be also to measure the oiling, hydration and pH of the skin of patients with AD after a series of treatments in a cryogenic chamber.

Condition or disease Intervention/treatment Phase
Quality of Life Atopic Dermatitis Other: whole body cryostimulation Not Applicable

Detailed Description:

In this research project will be performed 15 treatments in cryogenic chamber (1 once a day, every day, with a break on Saturdays and Sundays). Cryostimulation will be conducted in a cryochamber located in the Małopolska Cryotherapy Centre in Kraków, Poland (Polish: Małopolskie Centrum Krioterapii). The whole body cryostimulation (WBC) exposure will be administered in a special temperature-controlled unit which consists of two rooms (-60° and -120°C). Persons with any contraindications (both with AD and healthy) for whole body cryostimulation will be excluded from the study. Patients with AD in treatment by phototherapy, cyclosporin A, oral corticosteroids, which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and patients during or after immunotherapy, children and adolescents under 18 years of age, breast-feeding mothers and pregnant, patients with inflammatory diseases, infectious, autoimmune and cancer will be excluded from research.

The participants will be informed about how they should breathe and move in the cryochamber. Entry to the cryochamber will be preceded by a 30s acclimatization period in the vestibule at a temperature of -60° C, after which the subjects will go directly to the proper chamber (-120° C) for three minutes. During the procedure, all participants will be clothed in shorts, wool socks, gloves and hats or headbands for protection from frostbite, as well as wooden clogs. Additionally, participants will wear surgical masks with a layer of gauze over the mouth and nose for protection. Throughout the session, the participants will be under direct supervision of qualified doctor.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Cryostimulation on Selected Mediators of Inflammation and on the Level of Lubrication, Moisture and pH of the Skin of Patients With Atopic Dermatitis (AD)
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : November 13, 2019
Actual Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: a group of patients with AD
15 people with clinically diagnosed atopic dermatitis (AD), established on the basis of criteria Hanifin and Rajka
Other: whole body cryostimulation
In this research project will be performed 15 treatments in cryogenic chamber (1 once a day, every day, with a break on Saturdays and Sundays). Cryostimulation will be conducted in a cryochamber located in the Małopolska Cryotherapy Centre in Kraków, Poland (Polish: Małopolskie Centrum Krioterapii). The whole body cryostimulation (WBC) exposure will be administered in a special temperature-controlled unit which consists of two rooms (-60° and -120°C). Throughout the session, the participants will be under direct supervision of qualified doctor.

control group
15 healthy persons which will form the control group
Other: whole body cryostimulation
In this research project will be performed 15 treatments in cryogenic chamber (1 once a day, every day, with a break on Saturdays and Sundays). Cryostimulation will be conducted in a cryochamber located in the Małopolska Cryotherapy Centre in Kraków, Poland (Polish: Małopolskie Centrum Krioterapii). The whole body cryostimulation (WBC) exposure will be administered in a special temperature-controlled unit which consists of two rooms (-60° and -120°C). Throughout the session, the participants will be under direct supervision of qualified doctor.




Primary Outcome Measures :
  1. examination of moisturizing of the skin of each patient (AD group) [ Time Frame: 5 minutes before 1st treatment of WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  2. examination of moisturizing of the skin of each patient (control group) [ Time Frame: 5 minutes before 1st treatment of WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  3. examination of greasing of the skin of each patient (AD group) [ Time Frame: 5 minutes before 1st treatment of WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  4. examination of greasing of the skin of each patient (control group) [ Time Frame: 5 minutes before 1st treatment of WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  5. examination of the pH level of the skin of each patient (AD group) [ Time Frame: 5 minutes before 1st treatment of WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  6. examination of the pH level of the skin of each patient (control group) [ Time Frame: 5 minutes before 1st treatment of WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  7. examination of moisturizing of the skin of each patient (AD group) [ Time Frame: 5 minutes after 15th WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  8. examination of moisturizing of the skin of each patient (control group) [ Time Frame: 5 minutes after 15th WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  9. examination of greasing of the skin of each patient (AD group) [ Time Frame: 5 minutes after 15th WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigatinhg. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  10. examination of greasing of the skin of each patient (control group) [ Time Frame: 5 minutes after 15th WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigatinhg. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  11. examination of pH level of the skin of each patient (AD group) [ Time Frame: 5 minutes after 15th WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  12. examination of pH level of the skin of each patient (control group) [ Time Frame: 5 minutes after 15th WBC ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln), non-invasive skin tests investigating. Each patient will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  13. examination of moisturizing of the skin of each patient (AD group) [ Time Frame: 3 weeks from completion of treatments in the cryogenic chamber ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln),non-invasive skin tests investigating. Each subject will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  14. examination of moisturizing of the skin of each patient (control group) [ Time Frame: 3 weeks from completion of treatments in the cryogenic chamber ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln),non-invasive skin tests investigating. Each subject will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  15. examination of greasing of the skin of each patient (AD group) [ Time Frame: 3 weeks from completion of treatments in the cryogenic chamber ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln),non-invasive skin tests investigating. Each subject will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  16. examination of greasing of the skin of each patient (control group) [ Time Frame: 3 weeks from completion of treatments in the cryogenic chamber ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln),non-invasive skin tests investigating. Each subject will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  17. examination of pH level of the skin of each patient (AD group) [ Time Frame: 3 weeks from completion of treatments in the cryogenic chamber ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln),non-invasive skin tests investigating. Each subject will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.

  18. examination of pH level of the skin of each patient (control group) [ Time Frame: 3 weeks from completion of treatments in the cryogenic chamber ]
    using special device to the skin test (Courage - Khazaka Electronic, Köln),non-invasive skin tests investigating. Each subject will have a measurement on the inside of the forearm. The measuring probes will be applied directly to the skin. The result will be read on the measuring device.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • informed consent for research;
  • equal age and above 18 years of age;
  • no contraindications to cryostimulation procedures;
  • clinically diagnosed atopic dermatitis (people with AD);

Exclusion Criteria:

  • lack of informed consent for research
  • patients with AD in treatment by phototherapy, cyclosporin A, oral corticosteroids, which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and patients during or after immunotherapy,
  • children and adolescents under 18 years of age,
  • breast-feeding mothers and pregnant,
  • patients with inflammatory diseases, infectious, autoimmune and cancer

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): NCT03761199


Locations
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Poland
Magdalena Kępińska
Kraków, Poland, 31-589
Sponsors and Collaborators
University School of Physical Education, Krakow, Poland
Investigators
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Principal Investigator: Magdalena Kępińska, PhD University of Physical Education in Krakow, Poland
Principal Investigator: Anna Misiorek, PhD University of Physical Education in Krakow, Poland
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Responsible Party: University School of Physical Education, Krakow, Poland
ClinicalTrials.gov Identifier: NCT03761199    
Other Study ID Numbers: USPEKrakow
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University School of Physical Education, Krakow, Poland:
AD patients
whole body cryostimulation
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases