Positive results of a preliminary clinical evaluation

Introduction

Existing techniques for the aesthetic treatment of facial wrinkles and folds by injection include the use of hyaluronic acid, Botox, collagen and various other materials. Injection techniques are all associated with some degree of side effects, include hematomas, swelling and pain, which can dissuade patients from undergoing treatment. Manual injections can also cause papules to remain visible on the skin surface for two or three days following treatment, mainly due to the non-homogeneous volumes of the drops produced. The speed of injection is hard to control, and the more quickly the injection is performed, the more pain the patient feels. The repetitiveness of manual techniques and the viscosity of the products also lead to the practitioners experiencing muscle fatigue, further reducing the accuracy of the volume administered and the control of speed and depth.

The ANTEIS INJECTION SYSTEM is a new, automated electronic injection system for fillers and rejuvenation products, designed as a modern alternative to traditional injection procedures that provides increased accuracy, comfort, ease of use and safety. It is intended for local injection with Anteis aesthetic product lines, which include Esthélis Soft and Basic for superficial to mid-dermis injections, Fortélis for mid- or deep dermis injections of face skin tissues, and Mesolis and Mesolis+ for rejuvenation with superficial dermis injections of face or body skin tissues. It can be used in flow mode (only one movement is required, injection is regulated) and/or in drop mode (volume of papule is homogeneous and standardized, using a drop dosage). This article reports the results of a recently completed preliminary clinical evaluation of the ANTEIS INJECTION SYSTEM.

Clinical trial objectives

The objective of the clinical trial was to provide clinical evidence for the safety and efficacy of the ANTEIS INJECTION SYSTEM for the treatment of different facial wrinkles and folds with fillers and rejuvenation treatments, and to assess the strengths, limits, ease and mode of use of this device. The trial allowed the accumulation of data on how the Injection System is used by practitioners for different techniques, and on both practitioner and patient satisfaction.

Methods

A total of 193 patients in 8 centers were involved in this assessment. 130 patients were injected with Mesolis or Mesolis+ products for rejuvenation treatment, with all 8 practitioners participating. 63 patients were injected with the fillers Esthélis Soft, Esthélis Basic and/or Fortélis, with 6 practitioners participating. A total of 267 indications were treated with the Injection System in these patients: 92 with fillers and 175 for rejuvenation. In some cases the two treatments were combined. 64% of rejuvenation patients and 63% of filler patients had previously been injected manually. Outcomes were recorded and assessed through questionnaires and evaluation forms filled in by patients and practitioners.

Results

Use of ANTEIS INJECTION SYSTEM for rejuvenation treatment

The three main indications treated were facial hydration (65%), crow’s feet (12%) and neck (7%). The mode used most frequently for these indications was the drop mode (57% drop alone, 31% drop & flow). The lowest speed was selected for 69% of drop usages, facilitating the creation of homogeneous papules. 30G needles were used for 52% of the injections, while for another 46% of injections 32G needles were used, despite the fact that only 30G needles are provided in the Anteis boxes. With 32G needles, pain during treatment could be significantly reduced, the use of an anaesthetic before treatment could be avoided and fewer side effects were observed.

For the main indication performed in rejuvenation treatments, face hydration, an average of 1.2 ml of product were used for the whole face, drop mode with low speed and 32G needles were the most used parameters, and no anaesthesia was used in 74% of cases.

67% of patients stated that the injection was not painful and 88% did not feel any pain after injection. 75% of patients reported no side effects, and those reported were only slight redness immediately after the injection. 87% of patients were satisfied with the treatment. Among patients who had previously been injected manually, 66% claimed that the Injection System procedure is less painful.

In practitioners’ global assessment, 100% found the Injection System easy to install and handle and comfortable for injection, and 100% were satisfied with the results. 80% found the injections more precise than with manual injection. The main inconvenience mentioned was the time to install (40%), while the main advantage was the lack of pain for the patient (80%).

The following is a summary of the key characteristics observed for the ANTEIS INJECTION SYSTEM used for rejuvenation treatment:


Use of ANTEIS INJECTION SYSTEM with fillers

The main indications treated were nasolabial folds (47%) and bitter folds (11%), followed by cheeks (7%), lips (7%) and around the eyes (7%). Fortélis was the most used filler with the Injection System with 47% of injections, followed closely by Esthélis Basic with 45% of injections. Fortélis was used mainly in flow mode (62%), using a 27G needle for 85% of these injections. When used in drop mode a 27G needle was also used for all injections. Esthélis Basic and Esthélis Soft were used almost exclusively in flow mode, with a 30G needle used for 78% of these injections. Overall, the flow mode was used for 81% of the indications. 75% of fillers were injected under anaesthesia.

The main adverse events were redness (44%) and pain (27%), followed by itching (15%). Other adverse events each affected no more than 4% of patients. 68% of patients declared that the injection itself was not painful, and 86% of patients did not feel any pain after the injection. 72% of patients did not report any side effects. 89% of patients were satisfied with the treatment. Among patients who had previously been injected manually, most said that the use of the Injection System was painless, and none felt more pain than with manual injection.

In practitioners’ global assessment, 100% stated they were satisfied with the results. 60% found the ANTEIS INJECTION SYSTEM more comfortable for injection, and 60% said it was less painful for the patient and easier to inject than manually. 40% found the injection more precise and the depth of injection easier to control, while 60% found the speed easier to control. The main inconveniences mentioned were the time to install (40%) and loss of product (40%), while the main advantages were the lack of pain for the patient (80%), lack of adverse events (40%) and better control of injection (40%).

The following is a summary of the key characteristics observed for the ANTEIS INJECTION SYSTEM used for fillers:


Discussion

The ANTEIS INJECTION SYSTEM was designed for ease of use with all injection techniques, providing highly predictable doses of product. Freed from the need to control flow rate or drop volume and able to apply softer pressure, the physician is able to focus on the placement of the product, leading to greater precision and a more homogeneous application of the product within the desired plane, whether superficial, mid- or deep dermis. The Injection System also allows the use of smaller-diameter needles, and anaesthesia can be avoided altogether in the case of rejuvenation treatments. These properties provide greater comfort for the practitioner and lead to significantly reduced pain for the patient. The consistent results at all injection sites and enhanced integration into the dermis yield a better result and minimize bruising, redness and swelling. The ANTEIS INJECTION SYSTEM therefore represents a superior means of applying fillers and rejuvenation products compared to traditional manual injection techniques.

Conclusion

Altogether, these results demonstrate the safety and efficacy of the ANTEIS INJECTION SYSTEM for rejuvenation and filler injections. It presented no safety concerns and provided better control of depth, speed and volume than manual injections. As a consequence, patients experienced less pain and fewer other side effects and a singularly reduced downtime after rejuvenation treatment. These positive results were underscored by a global practitioner satisfaction rate of 100%.


 

 

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