Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators
Primary Purpose
Quality of Life, Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
whole body cryostimulation
Sponsored by
About this trial
This is an interventional basic science trial for Quality of Life focused on measuring AD patients, whole body cryostimulation
Eligibility 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
Sites / Locations
- Magdalena Kępińska
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
a group of patients with AD
control group
Arm Description
15 people with clinically diagnosed atopic dermatitis (AD), established on the basis of criteria Hanifin and Rajka
15 healthy persons which will form the control group
Outcomes
Primary Outcome Measures
examination of moisturizing of the skin of each patient (AD group)
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.
examination of moisturizing of the skin of each patient (control group)
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.
examination of greasing of the skin of each patient (AD group)
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.
examination of greasing of the skin of each patient (control group)
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.
examination of the pH level of the skin of each patient (AD group)
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.
examination of the pH level of the skin of each patient (control group)
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.
examination of moisturizing of the skin of each patient (AD group)
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.
examination of moisturizing of the skin of each patient (control group)
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.
examination of greasing of the skin of each patient (AD group)
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.
examination of greasing of the skin of each patient (control group)
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.
examination of pH level of the skin of each patient (AD group)
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.
examination of pH level of the skin of each patient (control group)
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.
examination of moisturizing of the skin of each patient (AD group)
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.
examination of moisturizing of the skin of each patient (control group)
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.
examination of greasing of the skin of each patient (AD group)
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.
examination of greasing of the skin of each patient (control group)
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.
examination of pH level of the skin of each patient (AD group)
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.
examination of pH level of the skin of each patient (control group)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03761199
First Posted
November 6, 2018
Last Updated
March 30, 2021
Sponsor
University School of Physical Education, Krakow, Poland
1. Study Identification
Unique Protocol Identification Number
NCT03761199
Brief Title
Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University School of Physical Education, Krakow, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Each participant will complete a Brief Questionnaire on Quality of Life, Life Satisfaction Index, Self Evaluation Questionnare and DERMATOLOGY LIFE QUALITY INDEX (before and after the WBC procedures).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Atopic Dermatitis
Keywords
AD patients, whole body cryostimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a group of patients with AD
Arm Type
Experimental
Arm Description
15 people with clinically diagnosed atopic dermatitis (AD), established on the basis of criteria Hanifin and Rajka
Arm Title
control group
Arm Type
Other
Arm Description
15 healthy persons which will form the control group
Intervention Type
Other
Intervention Name(s)
whole body cryostimulation
Intervention 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). Throughout the session, the participants will be under direct supervision of qualified doctor.
Primary Outcome Measure Information:
Title
examination of moisturizing of the skin of each patient (AD group)
Description
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.
Time Frame
5 minutes before 1st treatment of WBC
Title
examination of moisturizing of the skin of each patient (control group)
Description
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.
Time Frame
5 minutes before 1st treatment of WBC
Title
examination of greasing of the skin of each patient (AD group)
Description
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.
Time Frame
5 minutes before 1st treatment of WBC
Title
examination of greasing of the skin of each patient (control group)
Description
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.
Time Frame
5 minutes before 1st treatment of WBC
Title
examination of the pH level of the skin of each patient (AD group)
Description
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.
Time Frame
5 minutes before 1st treatment of WBC
Title
examination of the pH level of the skin of each patient (control group)
Description
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.
Time Frame
5 minutes before 1st treatment of WBC
Title
examination of moisturizing of the skin of each patient (AD group)
Description
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.
Time Frame
5 minutes after 15th WBC
Title
examination of moisturizing of the skin of each patient (control group)
Description
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.
Time Frame
5 minutes after 15th WBC
Title
examination of greasing of the skin of each patient (AD group)
Description
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.
Time Frame
5 minutes after 15th WBC
Title
examination of greasing of the skin of each patient (control group)
Description
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.
Time Frame
5 minutes after 15th WBC
Title
examination of pH level of the skin of each patient (AD group)
Description
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.
Time Frame
5 minutes after 15th WBC
Title
examination of pH level of the skin of each patient (control group)
Description
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.
Time Frame
5 minutes after 15th WBC
Title
examination of moisturizing of the skin of each patient (AD group)
Description
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.
Time Frame
3 weeks from completion of treatments in the cryogenic chamber
Title
examination of moisturizing of the skin of each patient (control group)
Description
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.
Time Frame
3 weeks from completion of treatments in the cryogenic chamber
Title
examination of greasing of the skin of each patient (AD group)
Description
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.
Time Frame
3 weeks from completion of treatments in the cryogenic chamber
Title
examination of greasing of the skin of each patient (control group)
Description
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.
Time Frame
3 weeks from completion of treatments in the cryogenic chamber
Title
examination of pH level of the skin of each patient (AD group)
Description
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.
Time Frame
3 weeks from completion of treatments in the cryogenic chamber
Title
examination of pH level of the skin of each patient (control group)
Description
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.
Time Frame
3 weeks from completion of treatments in the cryogenic chamber
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Kępińska, PhD
Organizational Affiliation
University of Physical Education in Krakow, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Misiorek, PhD
Organizational Affiliation
University of Physical Education in Krakow, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magdalena Kępińska
City
Kraków
ZIP/Postal Code
31-589
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators
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