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

Sponsor

University School of Physical Education, Krakow, Poland (Other)

Overall Status

Completed

CT.gov ID

NCT03761199

Collaborator

(none)

Enrollment

Location

Arms

11.6

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Atopic Dermatitis	Other: whole body cryostimulation	N/A

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.

Study Design

Study Type:

Interventional

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 :

Nov 26, 2018

Actual Primary Completion Date :

Nov 13, 2019

Actual Study Completion Date :

Nov 13, 2019

Arms and Interventions

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.
Other: 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.

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

Other: control group

15 healthy persons which will form the control group

Other: whole body cryostimulation

Outcome Measures

Primary Outcome Measures

examination of moisturizing of the skin of each patient (AD group) [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.
examination of moisturizing of the skin of each patient (control group) [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.
examination of greasing of the skin of each patient (AD group) [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.
examination of greasing of the skin of each patient (control group) [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.
examination of the pH level of the skin of each patient (AD group) [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.
examination of the pH level of the skin of each patient (control group) [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.
examination of moisturizing of the skin of each patient (AD group) [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.
examination of moisturizing of the skin of each patient (control group) [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.
examination of greasing of the skin of each patient (AD group) [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.
examination of greasing of the skin of each patient (control group) [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.
examination of pH level of the skin of each patient (AD group) [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.
examination of pH level of the skin of each patient (control group) [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.
examination of moisturizing of the skin of each patient (AD group) [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.
examination of moisturizing of the skin of each patient (control group) [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.
examination of greasing of the skin of each patient (AD group) [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.
examination of greasing of the skin of each patient (control group) [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.
examination of pH level of the skin of each patient (AD group) [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.
examination of pH level of the skin of each patient (control group) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magdalena Kępińska	Kraków		Poland	31-589

Sponsors and Collaborators

University School of Physical Education, Krakow, Poland

Investigators

Principal Investigator: Magdalena Kępińska, PhD, University of Physical Education in Krakow, Poland
Principal Investigator: Anna Misiorek, PhD, University of Physical Education in Krakow, Poland