Evaluation test and analysis of a microneedle and iontophoresis based medical device “CELLADEEP Patch” in skin improvement on ex vivo human‐derived skin tissue models

Author:

Zhang Xin Rui12,Jin Yong Xun12,Chien Pham Ngoc23,Tien Trinh Thi Thuy23,Zhou Shu Yi12,Giang Nguyen Ngan24,Le Linh Thi Thuy25,Nam Sun Young23,Heo Chan Yeong124

Affiliation:

1. Department of Plastic and Reconstructive Surgery College of Medicine Seoul National University Seoul South Korea

2. Department of Plastic and Reconstructive Surgery Seoul National University Bundang Hospital Seongnam South Korea

3. Korean Institute of Nonclinical Study Seongnam South Korea

4. Department of Medical Device Development College of Medicine Seoul National University Seoul South Korea

5. Department of Biomedical Science College of Medicine Seoul National University Seoul South Korea

Abstract

AbstractBackgroundMicroneedles are tiny needles, typically ranging from tens to hundreds of micrometers in length, used in various medical procedures and treatments. The tested medical device named “CELLADEEP Patch” a dissolvable microneedle therapy system (MTS), made of hyaluronic acid and collagen. And the iontophoresis technique is also applied in the system. The study aimed to evaluate the effectiveness of the “CELLADEEP Patch” in skin improvement.MethodsEx vivo human‐derived skin tissue models were used in this study and they were divided into three different groups, namely, the Untreated Group, the Negative Control Group, and the Test Group respectively. The Untreated Group received no treatment measures, the Negative Control Group was exposed to ultraviolet B radiation (UVB) irradiation, and the Test Group was exposed to UVB irradiation and treated with “CELLADEEP Patch”. Skin moisture content, transdermal water loss, and skin elasticity were evaluated by three clinical devices. Additionally, histological staining and related mRNA expression levels were also analyzed.ResultsThe results of skin moisture content, transdermal water loss, and skin elasticity evaluation consistently illustrated that the application of “CELLADEEP Patch” led to remarkable skin improvement. And the analysis of histological staining images also confirmed the effectiveness of the “CELLADEEP Patch”, especially for increasing collagen density. Moreover, the upregulation of Collagen type 1 a (COL1A1) and hyaluronan synthase 3 mRNA expression and the decrease of Matrix metalloproteinase 1 (MMP‐1) and Interleukin‐1 beta (IL‐1β) mRNA expression reflected its wrinkle improvement, moisturizing and anti‐inflammation function.Conclusion“CELLADEPP Patch”, the MTS combined with the iontophoresis technique, exhibits its effectiveness in moisturizing, skin elasticity improvement, and anti‐inflammatory function when applied to ex vivo human‐derived skin tissue models in experiments. The study has contributed to the understanding of the “CELLADEPP Patch” and laid the foundation for subsequent animal experiments and clinical trials.

Publisher

Wiley

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