In vitro study of RRS® Silisorg CE Class III medical device composed of silanol: effect on human skin fibroblasts and its clinical use

Abstract

Introduction

Silanol (organic silicon) has been used for decades in the treatment of skin photoaging as it stabilizes and maintains skin structures through hydrogen bonding electrostatic interaction with extracellular matrix (ECM) proteins or glycosaminoglycans. Organic silicon-based products are often presented as silanol derivatives which are currently associated to other structural molecules such as orthohydroxybenzoate, carboxymethyl theophylline alginate, ascorbate, acetyltyrosine, sodium lactate or mannuronate. Consequently, organic silicon formulations may differ substantially between the medical devices available on the market, which may result in additional effect on the skin. Therefore, there is a real need for a better characterization of the products in terms of their action on human skin and in vitro skin model.

Materials and methods

In this in vitro study, the effect of RRS® Silisorg was analyzed. RRS® Silisorg is a dermal implant (CE Class III medical device) containing monomethylsilanol mannuronate associated to an antioxidant resveratrol. Skin fibroblast viability and capacity to induce the production of key ECM genes were evaluated in the presence of different concentrations of RRS® Silisorg. The key ECM genes selected were collagen type I, elastin and hyaluronan synthase type 2 (HAS2), which is the cellular enzyme responsible for high-molecular weight hyaluronic acid (HA) production. Viability was evaluated through 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay and expression was quantified by quantitative polymerase chain reaction.

Results

RRS® Silisorg increased fibroblast gene expression of HAS2 in the first 24 hours, 25 times in the presence of 1 mg/mL of solution, followed by a collagen type I gene expression (4.7 times) and elastin expression (2.5 times) increase after 48 hours.

Conclusion

These results demonstrate that the silanol-based medical device RRS® Silisorg sustains HA, collagen and elastin production in human skin fibroblasts in vitro.

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Keywords:

• dermal implant
• mesotherapy
• hyaluronic acid
• collagen
• organic silicon
• photoaging

Acknowledgments

All in vitro experiments and collection of data corresponding to the experiments were performed by Eurofins BioPharma Product Testing Spain SLU, an external independent certified laboratory. Patient pictures were kindly provided by Dr Katar-zyna Luch, esthetic medicine practitioner. The patient provided written informed consent for the publication of her images.

Author contributions

All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work.

Disclosure

All authors of the paper belong to the company Skin Tech Pharma Group. This paper has been revised by Eurofins BioPharma Product Testing Spain SLU to validate that all the data exposed conform with the results obtained. The authors report no other conflicts of interest in this work.