The incidence of atopic eczema in the population reaches generally up to 25%. Skin diseases such as Atopic eczema and Psoriasis vulgaris are a worldwide problem. Use of topical corticosteroids is the first-line treatment for atopic dermatitis flare-ups. Last individual case studies led to the hypothesis: Baths with microbubbles in tap water can significantly support the treatment of skin diseases. Microbubbles penetrate deep into the skin pores. Micro implosions occur on the pore walls, which mechanically affect nerve endings and vascular microcapillaries. In addition, due to the implosion of microbubbles, the mechanical effect leads to an increased release and flushing of substances contained in the skin pores. A total of 30 patients were selected for the study, of which 15 were in cluded in the Study Group and 15 in the Control Group. The effects were monitored on the objectively evaluable dermatological calculators PASI, EASI, SCORAD, and DLQI Score, Quality of life, and Number and condition of foci. The project responded to the hypothesis that microbubbles in the water phase, produced by special generators, in the size range of 1-100 µm, may in the future become a fundamental innovation in balneological treatment in the form of new treatment procedures.
Introduction
The incidence of atopic eczema in the population reaches up to 25%, which is at tributed to environmental, dietary, and lifestyle influences. Skin diseases such as Atopic eczema and Psoriasis vulgaris are a worldwide problem. American Association of Dermatological Sciences (American Academy of Dermatology Association) reports that atopic eczema affects up to 25 percent of the world's population in varying degrees, and 2% suffer from a reduced quality of life. It is estimated that in approximately 60 percent of the population with this diagnosis, atopic eczema develops already in the first year of life, and in ninety percent of the population with this diagnosis, the disease develops before the age of 5. However, atopic eczema can also start during puberty or even later.
The preclinical study aimed to verify the hypothesis about the positive effect of a water bath with microbubbles for the supportive treatment of selected skin diseases – Psoriasis vulgaris and Atopic eczema. In addition to the results listed below, the preclinical analysis provided important data for the formulation of the assignment of follow-up clinical studies. The therapeutic application of a microbubble water bath for skin diseases is not completely new. The original use of microbubbles mainly focused on wellness procedures, Balneo and PRM Research Journal 2023, 14(2) Balneo and PRM Research Journal 2023, 14, 2. 2 of 8 which is still the case today.
At the beginning of the 21st century, observational case studies of the application of microbubble baths appeared [7-9]. Relief was mostly achieved in individual cases of severe skin disease. However, despite the positive signal information about the effects of micro and nanobubbles on skin diseases, clinical studies have so far been lacking. 2. Results 2.1 Subjects The selected probands had to fulfill the following criteria: 2.1.1 Administrative criteria Signature of the patient's informed consent - proband or signature of his legal representatives in the case of minor patients. Thus, consent to participate in the study was confirmed after they were fully informed about the purpose, procedures, and possible risks of the study. 2.1.2 Indicative criteria for inclusion in the study Patients with a diagnosis of Psoriasis Vulgaris with skin manifestations of psoriatic foci intended for balneological therapy. Patients diagnosed with atopic eczema with skin manifestations of atopic eczema are in tended for balneological therapy. In patients without gender differences, in the age category 5–70 years, 5 probands were younger than 5 years. 2.1.3
Contraindication criteria for exclusion from the study Tumor diseases or after their treatment, immunodeficiency syndrome or after its treatment, other systemic diseases, acute inflammatory diseases, diabetes mellitus, and patients in the age category younger than 2 years and older than 70 years. 2.2 Evaluation of data obtained The condition improved in both the Study and Control groups. The final report stated that probands with a lower initial disability score in almost all monitored indicators were included in the Control group. On the contrary, patients with greater disabilities, i.e., significantly higher initial values in the mentioned indicators, were mostly included in the Study Group. The selection procedures were always consulted with the clinical spa work place in such cases and gradually improved. For the continuation of preclinical analysis and clinical tests, it is assumed that subgroups will be established for each evaluation calculator, which at least partially eliminates the unequal starting point, i.e., the initial health status of the patient. In general, a comparable effect of therapy for skin disease with elements of chronicity occurs mostly only after a significantly longer therapeutic effect. In the interests of the objectivity of the follow-up clinical trial, it will be necessary to establish stricter rules for deciding which treatment plan will be chosen based on the established input data.
Despite the aforementioned problem of grouping, the completed investigation of 15 probands in the Study Group demonstrated a significant benefit of the microbubble bath. The significantly heavier initial severity of disability of the members of the study group, characterized by dermatological indices, must then be correctly interpreted in the context of the influence of severe disability in comparison to the effect of the normal therapeutic spa process in the Control group. There are more details in the subsequent description of the evaluation indices. Photographic documentation, reports from the initial checkup, and subsequent reports document the beneficial effect of microbubbles on skin diseases.
There was no harmful effect of microbubbles in a standard tap water bath. Due to the theoretical risk of an inappropriate effect, the objective effect on the stra tum corneum will have to be investigated in follow-up studies at the level of effects on biomarkers and immunomarkers. This should identify the refinement of the list of contra indicated conditions in subsequent standard clinical trials. No manufacturer of equipment for the generation of microbubbles, which would have the possibility of regulating their physicochemical properties, has been identified in the world. [7-9]. The authors of this study, therefore, approached several manufacturers of microbubble technology for water baths to develop such devices with the ability to control the size, shape, number of bubbles, and other selected physicochemical properties. For the continuation of preclinical analysis and clinical tests, it is assumed that sub groups will be established for each value calculator, which at least partially eliminates the unequal starting i.e., entry, and health status of the patient. In general, a comparable effect of therapy for skin disease with elements of chronicity occurs mostly only after a signifi cantly longer therapeutic effect. In the interests of the objectivity of the follow-up clinical trial, it will be necessary to establish stricter rules for deciding which treatment plan will be chosen based on the established input data. In other words, whether the patient will be included in the project and in which group.
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