NCT03761199

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University School of Physical Education, Krakow, Poland · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Quality of Life
• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2018-12-03
• Last updated: 2021-04-02

Locations

1 site across 1 country: Poland