Complete regeneration of the skin barrier in atopic dermatitis
A practice and results-oriented application study with a new matrix containing EGF and ceramides
D. Scherrinsky, E. Kochs
Summary
From 2019 to 2023, an application study on the regeneration of the skin barrier was carried out on 150 predominantly adult study participants aged 16 to 72 years and 6 children aged 5-7 years. The study participants were treated with the newly developed cosmetic products PURE | 5 Matrix and PURE | 5 Powder using an interval treatment (three applications at intervals of 7 to 10 days each). PURE | 5 is a novel, matrix-based cosmetic product with medical-grade EGF [1,2,3] for use in atopic dermatitis. These products consist of bovine gelatin crosspolymer [3], human EGF (epidermal growth factor) [1,2,3] and ceramides [4,5].
In the study the criteria of skin acceptance, effectiveness, tolerability, reduction of itching and dryness, and the increase in skin elasticity and moisture were examined. The study participants were questioned after each application and 60 days as well as 12 months after the first application. If possible, the condition of the skin barrier was checked again after 2, 3 and 5 months. All participants had been diagnosed with atopic dermatitis for years and all had been treated for this condition by their trusted doctor or dermatologist.
All study participants showed complete and lasting regeneration of the skin barrier. One of the 150 study participants, whose skin barrier was severely damaged, required a 4th application six weeks after the third. This study participant also subsequently achieved complete and lasting recovery of the skin barrier.
As this study is an application study, the results should be further verified by scientific studies.
The ongoing research in the field of skin care and regeneration has led to remarkable progress in recent years. One of these innovations is the product PURE | 5 Matrix, which was originally used in the aesthetic field to regenerate aged skin and has now been transferred to other application possibilities. During these applications, it was found that PURE | 5 Matrix can not only reduce skin aging but also regenerate the impaired skin barrier in the presence of atopic dermatitis. This surprising discovery prompted GNS (Global New Skin Cosmetics, Germany) to conduct a specific application study on atopic dermatitis patients to investigate the regenerative capacity of the damaged skin barrier and the sustainability of the results.
As part of a comprehensive literature search on existing topical and non-invasive treatment options for regenerating the skin barrier, it turned out that there were no application studies on humans but only tests on mouse models. The present application study in a small population of 30 probands originally had the aim of examining the skin tolerance and regeneration potential of the products PURE | 5 Matrix and PURE | 5 Powder, both of which contain epidermal growth factor (EGF) [1,2,3] and ceramide [4,5].
The recorded parameters included skin acceptance, effectiveness, tolerability, reduction of itching and dryness, as well as the increase in elasticity and moisture of the skin.
However, in the course of the study, the number of participants was expanded considerably. Instead of the planned 30 participants, 156 subjects with a total of 205 application sites were ultimately included. This expanded cohort enabled a more comprehensive assessment of the product applications and their results. The study participants were questioned about their experiences and the observed effects or the sustainability of the results after each application, as well as after 60 days and after 12 months, respectively.
With this application study, GNS aims to gain more in-depth knowledge about the effectiveness and tolerability of PURE | 5 Matrix and PURE | 5 Powder in the cosmetic „interval care“ developed by GNS for the damaged skin barrier of people suffering from atopic dermatitis. The results are intended to help expand the options for atopic dermatitis patients and sustainably improve the quality of life of those affected.
After developing the intensive care products PURE | 5 Matrix and PURE | 5 Powder, the focus was on the question of the optimal exposure time and application frequency in order to achieve the best possible results in skin regeneration and rejuvenation. Extensive tests and observations resulted in a three-time application cycle, characterized by intervals of 7 to 10 days and an exposure time of 45 minutes per application. GNS refers to this procedure as interval care, as only three applications within three weeks are required to achieve significant skin regeneration. This interval care is used both for applications to regenerate the skin barrier and for anti-aging applications.
Recruiting
The subjects were recruited through trusted doctors, self-help groups and through personal recommendations between sufferers of successfully treated patients. After completion of the main study, the pool of study participants expressed the desire to GNS to also treat younger children.
As a result, from 2023 to 2024, applications were carried out on six children between the ages of 5 and 7, 4 of whom were female and 2 male. A total of 100 female and 56 male study participants aged 5-72 years took part in the application study.
Methodology
In total, PURE | 5 was used on 150 adult study participants and six children between the ages of 5 and 7. Each participant was first informed about the application process in a detailed consultation. During this consultation, the defective skin areas were recorded, documented, and the subjects‘ expectations and wishes were determined. After receiving informed consent, the application was initiated.
In the adult subjects, three applications were carried out, with one exception: one severe case also required
a fourth application session. After cleaning and preparing the skin using microdermabrasion or a skin roller, it was moistened with sterile water. Depending on the size of the area to be treated, either the PURE | 5 Matrix or the PURE 5 | Powder, which had previously been dissolved in sterile water, was applied. The treatment was carried out three times at intervals of seven to ten days. The material was applied topically to the skin and then covered with an occlusion film for 45 minutes. After the exposure time, the film and the remaining product residues were removed.
For the children group, the number of applications varied between one and three sessions and the skin was only cleansed. All younger children were treated with PURE | 5 Powder, with the exposure time limited to 30 minutes.
Each treatment was comprehensively documented in the form of questionnaires and photo documentation. Photos were taken before, during and after the applications to document the course and results of the applications. The photo documentation confirmed the sustainability of the intensive care of the skin barrier even after 12 months.
Results and mode of action
Evaluation of the study participant questionnaires – study participant satisfaction
The evaluation of the study participant questionnaires indicated that before using PURE | 5, in addition to itching and the resulting insomnia and depressive state, the visual component also plays a major role in the participant’s satisfaction of treatment. Defective areas of the skin barrier, especially on the face, arms and legs, were perceived as particularly stressful. Our expectations for the use of PURE | 5 were therefore initially focused on reducing pruritus and regenerating the skin barrier, which should also reduce visual issues at the same time.
The study participants were asked about their satisfaction with the application after each application, after 60 days and after 12 months respectively. 99.3% of the study participants were very satisfied with the results of the intensive care application.
Results
All study participants (including children) showed an improved skin condition after completing the treat- ment, although in one case a fourth application was necessary for the adult study participants. In one study participant with a larger defect area, this was only completely regenerated after the fourth session. All study par- ticipants confirmed the increase in quality of life and would recommend this application.
We attribute the effectiveness of the non-invasive, purely topical application to the two active ingredients ceramide [4,5] and human EGF (epidermal growth factor). [1,2,3] Ceramide [4,5] is an essential component of the intact skin barrier. If there is a ceramide deficiency, the skin becomes dry, cracked and less elastic, making it easier for allergens, bacteria and viruses to penetrate.
EGF [1,2,3] controls, among other things, the body‘s own synthesis of collagen, elastin and hyaluronic acid, which helps to improve the
skin structure and function, and is also known as a filaggrin booster. A filaggrin deficiency can trigger neurodermatitis. [1,6]
For PURE | 5 to work optimally, a matrix is needed that can release the EGF [1,2,3] with a time delay. In addition, the matrix acts as a guide rail and enables the migration of new cells. Both components are therefore embedded in a gelatin crosspolymer. [3,7,8] Gelatin has low antigenicity and high biocompatibility. [7,8]
Conclusion
We attribute the successful use of PURE | 5 in all study participants to the intensive care with the active ingredients essential for the skin barrier, which are embedded in a gelatin crosspolymer. [7,8] This polymer also serves as a guide rail. PURE | 5 represents a novel approach for use in neurodermatitis with long-term success. Further scientific studies should contribute to the precise mode of action of PURE 5 and confirm the results presented.
Funding
The study was funded by the company GNS. The application was free for all study participants.
Statement on data availability:
Not applicable.
Conflicts of interest:
D. Scherrinsky is the owner and managing director of GNS, E. Kochs is a consultant to GNS and the authors declare that no further conflicts of interest exist.
Correspondence:
d.scherrinsky@gns-cosmetics.de
Copyright:
© 2024 by authors
References
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4. Urara Yokose et al. BMC Dermatology (2020) 20:6; https://doi.org/10.1186/s12895- 020-00102-1
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