<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761199</url>
  </required_header>
  <id_info>
    <org_study_id>USPEKrakow</org_study_id>
    <nct_id>NCT03761199</nct_id>
  </id_info>
  <brief_title>Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University School of Physical Education, Krakow, Poland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University School of Physical Education, Krakow, Poland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the planned study will be to evaluate the effect of repeated cryostimulation&#xD;
      treatments on immunological, morphological, and biochemical indicators of the peripheral&#xD;
      blood of patients with atopic dermatitis (AD). The aim of the study will be also to measure&#xD;
      the oiling, hydration and pH of the skin of patients with AD after a series of treatments in&#xD;
      a cryogenic chamber.&#xD;
&#xD;
      Each participant will complete a Brief Questionnaire on Quality of Life, Life Satisfaction&#xD;
      Index, Self Evaluation Questionnare and DERMATOLOGY LIFE QUALITY INDEX (before and after the&#xD;
      WBC procedures).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this research project will be performed 15 treatments in cryogenic chamber (1 once a day,&#xD;
      every day, with a break on Saturdays and Sundays). Cryostimulation will be conducted in a&#xD;
      cryochamber located in the Małopolska Cryotherapy Centre in Kraków, Poland (Polish:&#xD;
      Małopolskie Centrum Krioterapii). The whole body cryostimulation (WBC) exposure will be&#xD;
      administered in a special temperature-controlled unit which consists of two rooms (-60° and&#xD;
      -120°C). Persons with any contraindications (both with AD and healthy) for whole body&#xD;
      cryostimulation will be excluded from the study. Patients with AD in treatment by&#xD;
      phototherapy, cyclosporin A, oral corticosteroids, which are topical calcineurin inhibitors&#xD;
      such as pimecrolimus and tacrolimus and patients during or after immunotherapy, children and&#xD;
      adolescents under 18 years of age, breast-feeding mothers and pregnant, patients with&#xD;
      inflammatory diseases, infectious, autoimmune and cancer will be excluded from research.&#xD;
&#xD;
      The participants will be informed about how they should breathe and move in the cryochamber.&#xD;
      Entry to the cryochamber will be preceded by a 30s acclimatization period in the vestibule at&#xD;
      a temperature of -60° C, after which the subjects will go directly to the proper chamber&#xD;
      (-120° C) for three minutes. During the procedure, all participants will be clothed in&#xD;
      shorts, wool socks, gloves and hats or headbands for protection from frostbite, as well as&#xD;
      wooden clogs. Additionally, participants will wear surgical masks with a layer of gauze over&#xD;
      the mouth and nose for protection. Throughout the session, the participants will be under&#xD;
      direct supervision of qualified doctor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">November 13, 2019</completion_date>
  <primary_completion_date type="Actual">November 13, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>examination of moisturizing of the skin of each patient (AD group)</measure>
    <time_frame>5 minutes before 1st treatment of WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of moisturizing of the skin of each patient (control group)</measure>
    <time_frame>5 minutes before 1st treatment of WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of greasing of the skin of each patient (AD group)</measure>
    <time_frame>5 minutes before 1st treatment of WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of greasing of the skin of each patient (control group)</measure>
    <time_frame>5 minutes before 1st treatment of WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of the pH level of the skin of each patient (AD group)</measure>
    <time_frame>5 minutes before 1st treatment of WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of the pH level of the skin of each patient (control group)</measure>
    <time_frame>5 minutes before 1st treatment of WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of moisturizing of the skin of each patient (AD group)</measure>
    <time_frame>5 minutes after 15th WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of moisturizing of the skin of each patient (control group)</measure>
    <time_frame>5 minutes after 15th WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of greasing of the skin of each patient (AD group)</measure>
    <time_frame>5 minutes after 15th WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of greasing of the skin of each patient (control group)</measure>
    <time_frame>5 minutes after 15th WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of pH level of the skin of each patient (AD group)</measure>
    <time_frame>5 minutes after 15th WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of pH level of the skin of each patient (control group)</measure>
    <time_frame>5 minutes after 15th WBC</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of moisturizing of the skin of each patient (AD group)</measure>
    <time_frame>3 weeks from completion of treatments in the cryogenic chamber</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of moisturizing of the skin of each patient (control group)</measure>
    <time_frame>3 weeks from completion of treatments in the cryogenic chamber</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of greasing of the skin of each patient (AD group)</measure>
    <time_frame>3 weeks from completion of treatments in the cryogenic chamber</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of greasing of the skin of each patient (control group)</measure>
    <time_frame>3 weeks from completion of treatments in the cryogenic chamber</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of pH level of the skin of each patient (AD group)</measure>
    <time_frame>3 weeks from completion of treatments in the cryogenic chamber</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>examination of pH level of the skin of each patient (control group)</measure>
    <time_frame>3 weeks from completion of treatments in the cryogenic chamber</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Quality of Life</condition>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>a group of patients with AD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 people with clinically diagnosed atopic dermatitis (AD), established on the basis of criteria Hanifin and Rajka</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>15 healthy persons which will form the control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>whole body cryostimulation</intervention_name>
    <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.</description>
    <arm_group_label>a group of patients with AD</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent for research;&#xD;
&#xD;
          -  equal age and above 18 years of age;&#xD;
&#xD;
          -  no contraindications to cryostimulation procedures;&#xD;
&#xD;
          -  clinically diagnosed atopic dermatitis (people with AD);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of informed consent for research&#xD;
&#xD;
          -  patients with AD in treatment by phototherapy, cyclosporin A, oral corticosteroids,&#xD;
             which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and&#xD;
             patients during or after immunotherapy,&#xD;
&#xD;
          -  children and adolescents under 18 years of age,&#xD;
&#xD;
          -  breast-feeding mothers and pregnant,&#xD;
&#xD;
          -  patients with inflammatory diseases, infectious, autoimmune and cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalena Kępińska, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Physical Education in Krakow, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Misiorek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Physical Education in Krakow, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magdalena Kępińska</name>
      <address>
        <city>Kraków</city>
        <zip>31-589</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AD patients</keyword>
  <keyword>whole body cryostimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761199
org study id: USPEKrakow
nct id: NCT03761199
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: examination of moisturizing of the skin of each patient (AD group)
time frame: 5 minutes before 1st treatment of WBC
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.
measure: examination of moisturizing of the skin of each patient (control group)
time frame: 5 minutes before 1st treatment of WBC
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.
measure: examination of greasing of the skin of each patient (AD group)
time frame: 5 minutes before 1st treatment of WBC
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.
measure: examination of greasing of the skin of each patient (control group)
time frame: 5 minutes before 1st treatment of WBC
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.
measure: examination of the pH level of the skin of each patient (AD group)
time frame: 5 minutes before 1st treatment of WBC
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.
measure: examination of the pH level of the skin of each patient (control group)
time frame: 5 minutes before 1st treatment of WBC
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.
measure: examination of moisturizing of the skin of each patient (AD group)
time frame: 5 minutes after 15th WBC
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.
measure: examination of moisturizing of the skin of each patient (control group)
time frame: 5 minutes after 15th WBC
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.
measure: examination of greasing of the skin of each patient (AD group)
time frame: 5 minutes after 15th WBC
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.
measure: examination of greasing of the skin of each patient (control group)
time frame: 5 minutes after 15th WBC
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.
measure: examination of pH level of the skin of each patient (AD group)
time frame: 5 minutes after 15th WBC
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.
measure: examination of pH level of the skin of each patient (control group)
time frame: 5 minutes after 15th WBC
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.
measure: examination of moisturizing of the skin of each patient (AD group)
time frame: 3 weeks from completion of treatments in the cryogenic chamber
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.
measure: examination of moisturizing of the skin of each patient (control group)
time frame: 3 weeks from completion of treatments in the cryogenic chamber
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.
measure: examination of greasing of the skin of each patient (AD group)
time frame: 3 weeks from completion of treatments in the cryogenic chamber
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.
measure: examination of greasing of the skin of each patient (control group)
time frame: 3 weeks from completion of treatments in the cryogenic chamber
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.
measure: examination of pH level of the skin of each patient (AD group)
time frame: 3 weeks from completion of treatments in the cryogenic chamber
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.
measure: examination of pH level of the skin of each patient (control group)
time frame: 3 weeks from completion of treatments in the cryogenic chamber
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.
arm group label: a group of patients with AD
arm group type: Experimental
description: 15 people with clinically diagnosed atopic dermatitis (AD), established on the basis of criteria Hanifin and Rajka
arm group label: control group
arm group type: Other
description: 15 healthy persons which will form the control group
intervention type: Other
intervention name: whole body cryostimulation
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.
arm group label: a group of patients with AD
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Magdalena Kępińska, PhD
role: Principal Investigator
affiliation: University of Physical Education in Krakow, Poland
last name: Anna Misiorek, PhD
role: Principal Investigator
affiliation: University of Physical Education in Krakow, Poland
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No