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

• Published in: Skin research and technology 2024-07, Vol.30 (7), p.eSRT13784-n/a
• Main Authors: Zhang, Xin Rui, Jin, Yong Xun, Chien, Pham Ngoc, Tien, Trinh Thi Thuy, Zhou, Shu Yi, Giang, Nguyen Ngan, Le, Linh Thi Thuy, Nam, Sun Young, Heo, Chan Yeong
• Format: Article
• Language: English
• Subjects: Animal models; Animal research; CELLADEEP Patch; Clinical trials; Collagen; Collagen (type I); Collagen Type I - metabolism; Effectiveness; Elasticity; Gene expression; Humans; Hyaluronan synthase; Hyaluronic acid; Hyaluronic Acid - administration & dosage; Interleukin-1beta - metabolism; Iontophoresis; Iontophoresis - instrumentation; Iontophoresis - methods; Irradiation; Matrix metalloproteinase; Matrix Metalloproteinase 1 - metabolism; Matrix metalloproteinases; Medical devices; Medical equipment; Metalloproteinase; microneedle therapy system; Moisture content; Needles; Radiation measurement; Skin; Skin - radiation effects; Skin Aging - radiation effects; skin improvement; Skin tests; Staining; Transdermal Patch; Ultraviolet radiation; Ultraviolet Rays; Water content; Water loss; Water Loss, Insensible - radiation effects
• ISSN: 0909-752X; 1600-0846; 1600-0846
• DOI: 10.1111/srt.13784

Background Microneedles 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. Methods Ex 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. Results The 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.