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

NCT03761199 | Completed

• 1 other identifier: USPEKrakow
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Quality of Life; Atopic Dermatitis

Keywords

AD patients; whole body cryostimulation

Outcome Measures

Primary Outcomes (18)

• 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.

  5 minutes before 1st treatment of WBC

• 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.

  5 minutes before 1st treatment of WBC

• 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.

  5 minutes before 1st treatment of WBC

• 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.

  5 minutes before 1st treatment of WBC

• 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.

  5 minutes before 1st treatment of WBC

• 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.

  5 minutes before 1st treatment of WBC

• 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.

  5 minutes after 15th WBC

• 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.

  5 minutes after 15th WBC

• 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.

  5 minutes after 15th WBC

• 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.

  5 minutes after 15th WBC

• 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.

  5 minutes after 15th WBC

• 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.

  5 minutes after 15th WBC

• 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.

  3 weeks from completion of treatments in the cryogenic chamber

• 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.

  3 weeks from completion of treatments in the cryogenic chamber

• 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.

  3 weeks from completion of treatments in the cryogenic chamber

• 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.

  3 weeks from completion of treatments in the cryogenic chamber

• 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.

  3 weeks from completion of treatments in the cryogenic chamber

• 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.

  3 weeks from completion of treatments in the cryogenic chamber

Study Arms (2)

a group of patients with AD

EXPERIMENTAL

15 people with clinically diagnosed atopic dermatitis (AD), established on the basis of criteria Hanifin and Rajka

Other: whole body cryostimulation

control group

OTHER

15 healthy persons which will form the control group

Other: whole body cryostimulation

Interventions

whole body cryostimulation OTHER

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.

a group of patients with AD; control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University School of Physical Education, Krakow, Poland: lead

Study Sites (1)

Magdalena Kępińska

Krakow, 31-589, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Magdalena Kępińska, PhD

  University of Physical Education in Krakow, Poland

  PRINCIPAL INVESTIGATOR

• Anna Misiorek, PhD

  University of Physical Education in Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: December 3, 2018
• Study Start: November 26, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: April 2, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)