Safety and Efficacy of a Microneedling Device Used in Facial Aesthetics

Plain-language summary

Microneedling (MN), also referred to as collagen induction therapy, uses small needles to create mechanical injury to the skin. The basis of MN relies on physical trauma. It has been proposed that the trauma generated by needle penetration in the skin induces regeneration of the dermis The needles penetrate the stratum corneum and create small holes known as micro-conduits with minimal damage to the epidermis. MN therapy is widely used to improve the appearance of facial scars, stretch marks and rejuvenate photoaged skin. Recently, it has been shown that MN can improve skin wrinkles on the face. MN can be used alone or to increase absorption of topical medications, growth factors, or deliver radiofrequency directly to the dermis. The product tested is a microneedling device with 20 micro-needles of 1.00 mm depth penetration. This microneedling device is considered as a medical device in the US but not in Europe, according to Appendix XVI of the European regulation on medical devices 2017/745 of 5 April 2017. It is not yet commercialized neither in Europe nor in US. This first-in-man, pilot, clinical study is designed to first confirm the cutaneous tolerance of the device and provide some first data on device performance. For this purpose, 33 subjects with mild to moderate wrinkles on the face and seeking improvement of his/her face aspect, will be treated on Day 0 and Day 30 with the microneedling device on the face. Follow-up visits will be done 30 and 60 days after first treatment. Treatment Site Reactions (TSR) and Adverse reactions (ARs) will be collected to evaluate the device safety. Change from baseline of wrinkle severity and Global Aesthetic Improvement Scale (GAIS) will be used to evaluate product performance. Subject evaluation will also be analysed, and photos will be taken to illustrate device effect.

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