Non‐surgical rhinoplasty technique: An innovative approach for nasal reshaping with hyaluronic acid fillers

Nonsurgical rhinoplasty has become increasingly popular among patients who want to improve the aesthetic aspects of their nose and do not accept the risks and/ or cost of surgical rhinoplasty. The main goal of the current paper was to present the preliminary aesthetic and clinical outcomes of an innovative injection technique for nose sculpturing with hyaluronic acid (HA) filler.


| INTRODUC TI ON
Rhinoplasty is one of the most popular surgeries worldwide, with more than 852.000 procedures worldwide performed in 2020. 1 Despite rhinoplasty has experienced significant advances over the last years, it remains currently one of the most challenging surgical aesthetic procedures. 2 Its anatomical variations, added to the impact of nose on the beauty of the face and its limited predictability, contribute to the complexity of this surgical aesthetic procedure. 2,3 Although the pandemic has led to a drop in the number of aesthetic procedures by 10.9% in 2020, non-surgical procedures (primarily fillers and hair removal treatments) continued to increase. 1 Due to the development of new hyaluronic acid dermal fillers, with good efficacy and safety profiles, nonsurgical rhinoplasty (NSR) has become increasingly popular among patients who want to improve the aesthetic aspects of their nose. 1,4 Additionally, NSR has been associated with lower cost, lower risk of adverse effects, and shorter downtime. 4,5 There are two main aesthetic indications for using dermal fillers in the nose, namely total dorsal augmentation and for correcting certain defects, anomalies and/or asymmetries. [6][7][8] Over the past several years, hyaluronic acid (HA) injectable dermal fillers have become the most popular agents for soft tissue contouring and volumizing. 1,9,10 Although they are not free of complications, fillers have a good safety profile, mainly if the appropriate filler is selected for each patient and procedure. 6,8 At present, the use of HA dermal fillers for NSR are based on the concepts learned from surgery, and are injected into the deep planes. 4,11,12 However, this technique is not free of certain controversy. 13 This paper aimed to present the preliminary aesthetic and clinical outcomes of an innovative injection technique for nose sculpturing with HA filler: The "LG Nose Reshaping Technique".

| Design
Retrospective analysis of a prospective clinical registry.
This study adhered to the tenets of the Declaration of Helsinki and the Good Clinical Practice/International Council for Harmonization Guidelines. All patients signed a written general consent to participate to studies, which has been drafted according to the guidelines of the Italian Society of Aesthetic Medicine (SIME), the Italian Society of Aesthetic Medicine and Surgery (SIES), and AGORA' Aesthetic Medicine Schools. Any information that could lead to an individual being identified has been encrypted or removed, as appropriate, to guarantee their anonymity.

| Study participants and Inclusion/ Exclusion criteria
Patients aged ≥18 years old who attended one of the study centers and were candidates for non-surgical nose reshaping between October 2019 and November 2020.
Patients with an initial nose morphotype that was not suitable for non-surgical reshaping; any previous aesthetic or non-aesthetic treatment of the nose (such as rhinoplasty, rhinofiller, or tumor removal, etc.); connective tissue disease; bleeding disorders; allergy to lidocaine; sensitivity to hyaluronic acid or polycaprolactone; antithrombotic therapy; pregnant or nursing women, or a diagnosis of dysmorphic syndrome were excluded of the study.

| Hyaluronic acid filler
A 25 mg/mL HA filler (Teosyal UltraDeep™, Teoxane Switzerland) with lidocaine 0.3% was used in all the subjects. This filler was designed for providing deep structural support with optimal lifting capacity. 14 It combines a high elastic Modulus (G') (which reflects the elasticity of the material when deformed), high cohesivity, and high resistance to compression. 14 These properties make it an ideal filler to create and restore facial volume. 14

| Aesthetic procedure
The 25 mg/mL HA filler was administered, in all the cases, by using a syringe with a fixed microneedle (30 G/8 mm).
Treatment strategy is based on the "3P Maneuvering" (Pinching, Pushing, and Pulling). 15 The capillary refill is checked (it should be less than 2 s). The Figure 1 shows the treatment strategy.
All patients were injected at three key nose points with the following order: Tip; Columella; Radix and Dorsum.   Patients were evaluated before the procedure between 21-30 days and 1 year after treatment.

| Retouch
Those patients who, according to the injector opinion, did not achieve the expected aesthetic results underwent a touch-up, 1 month after the first treatment session. Additionally, some patients needed a touch up because during first session phlogistic phenomena can One bolus (0.1-0.2 mL) is injected into the fibro-adipose tissue space to achieve the rotation of the tip. Afterward, two boluses of 0.02 mL each were administered, at a distance of 3 mm, along the entire length of the columella in the intercrural space to give support and projection to the tip. (C) Radix: A 0.05-0.1 mL bolus of the HA filler is injected perpendicularly to the level of the periosteum. Subsequently, two boluses (0.02 mL, each) were injected at 3 mm from the first one in the cranio-caudal direction. mask the real quantity of filler required so the aesthetic correction is not maintained when healing has occurred.

| Photographs
For each patient, standard photographs (Iphone 11pro. Infinite Loop, Cupertino 95014, CA, USA) of adequate quality were performed before and after the aesthetic procedure.
Each patient underwent front and profile projection photographs before and after treatment.

| Patient satisfaction
A five-points Likert scale ("Very Dissatisfied"; "Dissatisfied"; "Scarcely satisfy"; "Satisfied"; and "Very satisfied") was used to assess the degree of patient satisfaction with the treatment. The scale included the following questions: Are you satisfied with the treatment results?

| Outcomes
Primary study variable was the degree of patients' satisfaction.
Secondary end-points included the treatment efficacy (assessed by means photographs) and the safety profile.

| Patient satisfaction
Among the 101 subjects included in the study, 85 (84.2%) patients were very satisfied with the treatment results. The Figure 3 shows the degree of patients' satisfaction with the treatment outcomes.
The Figures 4-6 show the pre-and post-treatment photographs of three patients (two women and one man) who were very satisfied with the treatment outcomes.
After 1 year, 87 patients (86.1%) were still satisfied with the aesthetic outcome and durability. Additionally, 91 (90.1%) patients would like to undergo again a new rhinofiller treatment. At year-1 year the amount of filler used for the procedure ranged between 0.3-0.5 mL. Since the majority of patients had still significant amount of filler from the first session, a less amount of filler was needed to achieve correction.
The Figure 7 shows the results of a patient after a year of follow-up and those obtained after a touch-up session.

| Retouch
After 1 year of follow-up, touch-up was performed on 44 (44%) subjects 30 days after initial treatment. The mean amount of HA injected was 0.23 ± 0.1 mL (range: 0.10 mL-0.50 mL). It was especially made at the nose radix where phlogistic phenomena were more frequent.

| Safety
Seventy-six (75.3%) patients reported mild edema, which was successfully resolved without treatment in all the cases. Twenty-five (24.8%) patients had hematoma/bruising, which was successfully resolved with medical therapy.
Six (5.9%) patients reported moderate adverse events, two (2.0%) patients had an infection similar to folliculitis; two (2.0%) subjects had late erythema on the tip of the nose, which caused a more accentuated superficial vascular pattern; and two (2.0%) patients reported late edema during the course of two systemic infectious processes, which were successfully resolved with oral corticosteroids.
The Table 1 shows the different adverse events reported during study follow-up.

| DISCUSS ION
Minimally invasive aesthetic procedures have become increasingly popular over the last several years. Among them, HA filler injections have emerged as an effective, predictable, and safe strategy for addressing different aesthetic concerns. 1 The term non-surgical rhinoplasty makes reference to the use of injectable temporary fillers to correct aesthetic defects/asymmetries in selected areas of the nose for improving their appearance 5,16 .
It can be classified as primary, when the patient has had no previous procedures, or secondary, when used for corrections after surgical rhinoplasty. 17 Having an adequate knowledge of the nose anatomy is essential both to obtain predictable and satisfactory aesthetic outcomes, and to avoid possible adverse events. Listed from superficial to deep, the nose has different layers, namely skin; superficial fat; superficial musculoaponeurotic system; deep fat; perichondrium and periosteum; and nasal cartilages and nasal bones. 8 The vasculature of the nose deserves special attention when  18,19 In order to prevent or avoid vascular occlusions, it is crucial performing the injection into the avascular deep fat or below the superficial musculoaponeurotic system. 6 Non-surgical rhinoplasty is currently indicated for correcting mild aesthetic/cosmetic deficits of the nose for patients who either do not accept the cost and risk associated with traditional surgical rhinoplasty or have medical issues that contraindicate the procedure. 8  Over the past several years, HA injectable fillers have become the most popular agents for soft tissue contouring and volumizing. 1,8,9 Selecting the right filler, for the right procedure, and in the right patient is crucial for achieving good and predictable aesthetic results. The new HA fillers have greater longevity and rheological properties more conducive to facial contouring than earlier nonsurgical products. Different manufacturing-related factors, such as HA concentration, polymer chain length, crosslinking degree, or cross-linking technology have a relevant impact on filler properties.
Among the different aforementioned factors, crosslinking is essential to improve biomechanical properties while maintaining biocompatibility and biological activity. 21,22 Teosyal UltraDeep™ is a HA filler, performed with the RHA patented technology, with very long and-high molecular weight chains with a high degree of modification, which gives it a high projection capacity. Additionally, the high-molecular weight HA results in increased durability and clinically desirable mechanical properties. 14 Although the duration of the effects may vary from one patient to another, formulators have reported that the effects of the HA filler can last up to 12 months. 14 From a clinical perspective, our technique has provided very good and predictable aesthetic results, with an acceptable safety profile.
Regarding safety, the incidence of HA filler complications observed in the current study was low and mild in severity and all the adverse events were successfully resolved either without medication or with topical medication.
Although non-surgical rhinoplasty with HA filler injections is currently considered a safe procedure, it is not free of complications. Among them, blindness and skin necrosis have been reported as a consequence of filler injections in the nose. 23,24 Additionally, different complications have been associated with the use of dermal fillers, such as injection site reactions; infection; hypersensitivity; technical placement errors, vascular compromise, etc. 25,26 This study has some limitation that need to be taken into account when interpreting its results. The first one is its open-label design.
A prospective, double-blind, and randomized trial design would have been preferable. However, this work did not intend to compare techniques or HA fillers, but rather to present the preliminary results of an innovative minimally invasive injection technique for nose sculpturing, by using a filler with a high amount of HA (25 mg/ mL), and high G' and cohesivity. As an additional limitation, need to be mentioned that the current paper has not used objective methods that provide information about the morphometric changes induced by the treatment. However, since many of the aesthetic procedures, mainly the minimally invasive ones, are elective treatment, evaluating the patient's satisfaction with the treatment outcomes is crucial to know their perception.
Our registry continues to collect data that will provide information on the long-term results of this technique. Finally, it would have been interesting to use some objective measure to evaluate the aesthetic changes. However, we found it interesting to focus our research on aspects related to patient satisfaction, which, although subjective, provides very interesting information.

| CON CLUS ION
The results of the current study suggested that our nose sculpturing technique: The "LG Nose Reshaping Technique", by using hyaluronic  acid filler, is an effective, predictable, and relatively safe procedure with a high degree of patient satisfaction. Further studies will be needed to evaluate its long-term outcomes.

AUTH O R CO NTR I B UTI O N S
Dr. Giammarioli: Conception and design of the study, acquisition of data, interpretation of data, and revision of the work. Dr. Liberti: conception and design of the study, acquisition of data, interpretation of data, and drafting the manuscript.

ACK N OWLED G M ENTS
Medical writing and Editorial assistant services have been provided by Ciencia y Deporte S.L. Support for this assistance was funded by TEOXANE at the request of the investigator.

FU N D I N G I N FO R M ATI O N
Medical writing services has been provided by TEOXANE. TEOXANE did not participate in either data collection, analysis, or redaction of the manuscript. Neither honoraria nor payments were made for authorship.

CO N FLI C T O F I NTER E S T S TATEM ENT
None of the authors have any conflict of interest to declare.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

E TH I C A L S TATEM ENT
All procedures were in accordance with the ethical standards of the 1964 Helsinki declaration and its later amendments or comparable ethical standards, and the Good Clinical Practice/International Council for Harmonization Guidelines.

I N FO R M ED CO N S ENT
All patients signed a written general consent to participate to studies, which has been drafted according to the guidelines of the Italian Society of Aesthetic Medicine (SIME), the Italian Society of Aesthetic Medicine and Surgery (SIES), and AGORA' Aesthetic Medicine Schools.