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Expert Consensus on Injection Technique and Area-Specific Recommendations for the Hyaluronic Acid Dermal Filler VYC-12L to Treat Fine Cutaneous Lines

Authors Ogilvie P, Thulesen J, Leys C, Sykianakis D, Chantrey J, Safa M, Figueiredo V, Heydenrych I, Cavallini M, Langeland EK, Wetter A

Received 22 November 2019

Accepted for publication 17 March 2020

Published 5 April 2020 Volume 2020:13 Pages 267—274

DOI https://doi.org/10.2147/CCID.S239667

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Dr Jeffrey Weinberg


Patricia Ogilvie, 1 Jesper Thulesen, 2 Christophe Leys, 3 Dimitris Sykianakis, 4 Jonquille Chantrey, 5 Marva Safa, 6 Vitor Figueiredo, 7 Izolda Heydenrych, 8 Maurizio Cavallini, 9 Elin Kringen Langeland, 10 Anne Wetter 11

1SkinConcept, Munich, Germany; 2Clinic Aesthetica, Copenhagen, Denmark; 3Medical Skincare, Sint-Truiden, Belgium; 4Well Aging Clinic, Athens, Greece; 5Expert Aesthetics, Cheshire, UK; 6La Jouvence, Neuchâtel, Switzerland; 7Up Clinic Lisboa, Lisbon, Portugal; 8Cosmetic Dermatology Centre, Cape Town, South Africa; 9Servizio di Chirurgia Plastica, Centro Diagnostico Italiano, Milan, Italy; 10Injeksjonsspesialisten AS, Trondheim, Norway; 11Diagnostiskt Centrum Hud, Stockholm, Sweden

Correspondence: Patricia Ogilvie
SkinConcept - Private Practice for Dermatology, Theatinerstraße 46, 80333 Munich, Germany
Tel +49 89 24214750
Email skin-concept@hotmail.de

Background: VYC-12L is a hyaluronic acid (HA) injectable gel designed to treat fine cutaneous lines and improve skin quality attributes such as hydration and elasticity.
Objective: Expert consensus was sought on VYC-12L injection technique and primary treatment target areas.
Methods: A multinational group of aesthetic medicine clinicians (n = 128) attended product training and each identified ∼ 10 patients for VYC-12L. After treating their first and last patients, the clinicians completed a survey on preferred injection methodology/technique, including injection angle, volume, and spacing. An expert panel (n = 12) discussed survey results and their clinical experiences to obtain consensus on VYC-12L technique and appropriate treatment areas.
Results: Recommendations included micro-depot injections of VYC-12L into the deep dermis with a 32G ½ inch needle inserted at < 45º to the skin, spaced 0.5‒1.0 cm apart, with 0.01‒0.05 mL volume per injection (full-face total volume: ∼ 2 mL). Recommended primary treatment areas were the malar, perioral, neck, and décolletage regions. Injection techniques for different treatment areas/demographic characteristics were similar, with some variability in treatment approach. Patient selection criteria, pre- and post-treatment guidelines, and managing patient expectations are important components of treatment.
Conclusion: These consensus recommendations may assist clinicians in optimizing the treatment of fine lines with VYC-12L.

Keywords: consensus, hyaluronic acid, injectable dermal filler, dermis, skin aging, Juvéderm Volite

Introduction

The topographic appearance of facial skin can influence judgments of age, physical health and fitness, and psychological factors such as self-esteem and well-being.14 Skin smoothness, hydration, firmness, and texture are just a few of the attributes that contribute to overall skin appearance or skin quality.59 Poor skin quality results from a variety of intrinsic and extrinsic factors, such as age- and hormone-related structural changes and environmental stressors (eg, ultraviolet, infrared A, and ozone exposure); effects on the skin may include roughness, surface irregularities, and wrinkling.6,1015 Minimally invasive cosmetic procedures to improve skin appearance, such as chemical peels, laser skin resurfacing, and microdermabrasion, have increased in popularity over the last 2 decades, exceeding 3.1 million procedures in the United States in 2017.16,17

VYC-12 with lidocaine (VYC-12L [Juvéderm Volite]; Allergan plc, Dublin, Ireland) is a crosslinked HA injectable gel that was developed using the Vycross technology platform (Allergan plc, Dublin, Ireland) and was designed to treat superficial cutaneous depressions such as fine lines and to improve skin quality attributes such as hydration and elasticity.18 A prospective, single-center, single-arm study in 131 subjects with moderate to severe cheek skin roughness at baseline showed that a single treatment with VYC-12 without lidocaine was safe and effective for reducing skin roughness and fine lines up to 6 months and improving skin hydration up to 9 months.19 Most subjects (76.4–90.8%) reported significant improvements in satisfaction with skin at all time points through month 9 on the FACE‐Q Satisfaction With Skin scale, a validated patient-reported outcome measure, and more than 80% said they would recommend the treatment to a friend.20 A prospective, open-label, 2-center study also demonstrated that VYC-12 improved skin quality and texture for up to 6 months, based on both objective and subjective analysis methods, in 40 women aged 35 to 60 years presenting with facial lines, low skin hydration or brightness, and signs of chrono- or photoaging.21 This article provides consensus-based guidance and direction on VYC-12L injection technique, ideal treatment areas, and pre- and post-treatment management based on clinical experiences of aesthetic medicine clinicians and the author group.

Consensus Methodology

Experience Phase

A multinational group of 128 European aesthetic medicine clinicians participated in an initiative to gather real-world clinical experience on the use of VYC-12L. After attending a product training event, participants identified approximately 10 patient candidates for VYC-12L treatment. The clinicians each completed a survey after treating their first and last patients. The clinicians were asked to indicate their preferred injection methodology, including technique, depth and angle of injection, volume per injection, and spacing between injection sites; primary target areas of treatment; and pre- and post-injection advice. Survey questions and results from the experience phase are summarized in the Supplemental Table.

Consensus Phase

An expert panel of 12 international advisors convened in Paris, France, in January 2017 and reviewed the results of the survey (Supplemental Table). The advisors were selected and invited by Allergan to participate in this initiative based on their positive reputation in the aesthetic community and extensive clinical practice and/or clinical trial experience with VYC-12L. During the meeting, the advisors discussed their individual experiences using VYC-12L and established consensus on general injection technique; area-specific recommendations for the forehead, malar, perioral, neck, hands, and décolletage regions; and pre- and post-treatment management.

Consensus Recommendations

Injection Technique

Key recommendations for VYC-12L injection technique were to use micro-depot injections, inject into the deep dermis at an angle less than 45 degrees from the skin surface, and space injections approximately 0.5 to 1.0 cm apart (Table 1).2225 The depth and spacing of the injection may be individualized to the patient and the treatment area based on the severity level of the skin lines, roughness, and photodamage.

Table 1 Expert Panel Consensus on VYC-12L Injection Technique

Anatomical Region

The malar, perioral, neck, and décolletage regions were identified as primary target areas for VYC-12L treatment with area-specific injection techniques based on skin characteristics in the respective regions (Table 2).

Table 2 Area-Specific Recommendations for VYC-12L Injection Technique

The panel did not identify the forehead as a primary indication for injection in otherwise treatment-naïve patients. Forehead skin has different sebaceous properties than the other areas identified for treatment; specifically, greater sebum production in the forehead results in increased skin surface hydration and a better skin appearance. Further, patient concerns about the forehead generally relate to dynamic lines, typically addressed with a neuromodulator.22,26,27 However, clinical data have demonstrated the efficacy and safety of VYC-12 without lidocaine for the treatment of forehead lines, and there is clinical practice experience in this facial area.

The dorsum of the hands was not considered a primary target for VYC-12L treatment; visible or protruding tendons or veins in the hands would be best addressed by other HA-based products with greater lift capacity,28 such as VYC-17.5L (Juvéderm Vollure XC/Juvéderm Volift XC; Allergan plc, Dublin, Ireland). Based on the clinical experience of some members of the panel, however, VYC-12L may be used to improve the appearance of the skin on the hands without producing an excessive volumizing effect.

Pre- and Post-treatment Management

Specific recommendations for both patients and clinicians to observe before and after treatment with VYC-12L (Table 3)29 are largely consistent with pre- and post-treatment guidance for other HA-based dermal fillers.23,30,31 Specific training on the use of VYC-12L is essential in order to avoid potential side effects associated with HA dermal fillers.

Table 3 Pre- and Post-treatment Recommendations

Demographic-Based Treatment Considerations

Improvements in skin appearance with VYC-12L treatment are expected regardless of age, skin phototype, and ethnicity (Table 4).3236 However, there are specific considerations for treatment with VYC-12L in each group. For example, older individuals whose skin is highly damaged may require more volume or closely spaced injections compared with younger individuals. Further, VYC-12L would not typically be the first aesthetic treatment for older patients, who may have previously received neuromodulating or volumizing treatments, or may have undergone cosmetic procedures that involve greater downtime, such as laser skin resurfacing.37 Therefore, older patients (or patients with a previous history of aesthetic and/or cosmetic procedures) should be advised that VYC-12L involves minimal downtime in addition to other distinguishing treatment considerations.

Table 4 Demographic-Based Treatment Considerations

Patient Selection

A broad range of patients are appropriate for VYC-12L treatment (Table 5).18,38 Younger patients who have sun damage or concerns about the texture or lackluster appearance of their skin may be good candidates for VYC-12L as an early or initial aesthetic treatment. Based on personal observation, the panel commented that skin with low-grade acne scars also responds well to VYC-12L.

Table 5 Recommendations for Selecting Patients

Patient Expectations

In setting appropriate treatment expectations, patients may be counseled to expect visible results approximately 5 to 10 days after treatment, rather than immediately, and to experience effects for about 4 to 6 months. Increased, prolonged internal cutaneous moisturization was identified as a major driver of patient satisfaction with VYC-12L, and it was recommended that patient management and communication efforts emphasize such tangible effects more than the instant visibility of results. Clinicians might communicate anticipated results to patients using words such as luminosity, radiance, glow, and freshness, which may be easier for patients to visualize than improved skin quality. Clinicians may also share with patients that improvements in horizontal neck lines and décolletage skin may be particularly satisfying, as these results, in the opinion of the panel, may last the longest. Patients should also be made aware that some skin characteristics, such as uneven pigment and large pores, will not improve significantly.

Representative images of results before and after treatment with VYC-12L are presented in Figures 14. These figures demonstrate the effectiveness of VYC-12L for fine lines and skin appearance at 1-month post-treatment in patients who had no prior experience with the product.

Figure 1 Representative images of facial area (A) before treatment and (B) 1 month after injection of VYC-12L into cheek, jawline, and perioral area, 1.0 mL per side. Images courtesy of Jesper Thulesen, MD.

Figure 2 Representative images of décolletage (A) before treatment and (B) 1 month after 1.5-mL injection of VYC-12L. Images courtesy of Patricia Ogilvie, MD.

Figure 3 Representative images of neck (A) before treatment and (B) 1 month after 1.0-mL injection of VYC-12L. Images courtesy of Patricia Ogilvie, MD.

Figure 4 Representative images of cheek (A) before treatment, (B) 1 month after initial injection of VYC-12L, 0.5 mL per side, and (C) 2 weeks after second treatment with VYC-12L, 0.5 mL per side. Images courtesy of Izolda Heydenrych, MD.

Role of VYC-12L in an Aesthetic Treatment Plan

Treatment with VYC-12L may be performed in the same session as injection of neurotoxins or other facial rejuvenation procedures. For example, a study conducted in 45 patients aged 35 to 52 years demonstrated high patient satisfaction and multiple skin quality and texture improvements, including smoothness, brightness, hydration, elasticity, and tightness, when VYC-12L was combined with microinjections of onabotulinumtoxinA and fractional resurfacing laser treatments.39 However, the initial treatment with VYC-12L in the face may be best administered without facial volumizing treatments in the same session. This approach will allow the injector to gain experience with VYC-12L and its distinct effects on a patient’s skin independent of any changes in skin appearance resulting directly from the volumizer. It may be appropriate to combine VYC-12L and volumizing treatment in the face once clinical experience has been gained and clear expectations of the results of this combination can be determined. The use of VYC-12L in the neck or décolletage during the same session as a facial volumizing treatment is supported, because these treatment areas are distant from the face and results are more likely to be complementary.

Conclusions

These consensus recommendations provide important information to guide clinicians in the use of VYC-12L. They support clinicians in optimizing aesthetic outcomes for patients who are seeking enhancement of their skin appearance, whether because of extrinsic effects, such as photodamage, or intrinsic changes, such as skin aging. The expert panel concluded that VYC-12L is especially appropriate for treatment of the malar, perioral, neck, and décolletage regions using the same general injection technique, with some modifications based on region-specific skin and patient characteristics. Patients may expect skin appearance improvements with VYC-12L regardless of their age, sex, or ethnicity. VYC-12L can be part of a comprehensive aesthetic treatment plan for patients of any age.

VYC-12L has several features that differentiate it from other treatments intended to improve the appearance of the skin. For example, topical retinoids,40,41 photodynamic therapy,42 chemical peels,8,43 laser skin resurfacing,37 and nonablative skin rejuvenation devices44 are applied to the surface of the skin, whereas VYC-12L is injected intradermally, with the objective being long-term improvements in skin appearance.18 Treatment with injectable HA-based fillers has been shown to temporarily improve attributes of skin quality, by hydrating the dermis and stabilizing the structure of the extracellular matrix–supporting fibroblasts.45,46

Unlike targeted volumizing treatments, VYC-12L treatment involves covering the whole topographical area with evenly spaced intradermal injections followed by targeted injections to correct lines, depressions, and other modalities of concern in the skin. VYC-12L also requires strategic and systematic intradermal injections, unlike mesotherapy, which consists of random microinjections of noncrosslinked HA, vitamins, minerals, and amino acids into the superficial part of the dermis.27,47,48

Setting patient expectations is an important component of treatment with VYC-12L. VYC-12L is a reasonable option for patients who want more subtle improvements in the appearance of their skin. To this end, physician-patient communication is key; patient education should be focused on the palpable, rather than instantly visible, effects of the treatment (eg, increased, prolonged moisturization). As with other aesthetic treatment options, high-quality, standardized, and reproducible medical photography showing patients’ skin before and after treatment may be useful in helping patients to detect and appreciate the effects of treatment with VYC-12L.

Prior Presentation

A poster based on this paper was presented at the 13th Aesthetic and Anti-aging Medicine European Congress, September 15−17, 2017, Monte Carlo, Monaco. The poster’s abstract was made available to meeting attendees in the congress’ on-site abstract book.

Funding

This initiative was funded by Allergan plc, Dublin, Ireland. The consensus recommendations reached were not influenced by Allergan plc. Medical writing support for this article was provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, New Jersey, and was funded by Allergan plc.

Disclosure

P Ogilvie is a consultant, trainer, and principal investigator for Allergan plc, participated in an Allergan Juvéderm Volite advisory board, and received research funding for the clinical registration trial of VYC-12L. M Cavallini, J Chantrey, V Figueiredo, I Heydenrych, E Langeland, M Safa, D Sykianakis, J Thulesen, and A Wetter are investigators for Allergan plc and have participated in an Allergan Juvéderm Volite advisory board. J Chantrey received honorarium from Allergan, during the conduct of the study; honorarium for teaching from Allergan, outside the submitted work. V Figueiredo and E Langeland report personal fees, non-financial support from Allergan, outside the submitted work. I Heydenrych reports personal fees from Allergan, during the conduct of the study; personal fees, non-financial support from Allergan, personal fees from SkinCeuticals, outside the submitted work. C Leys is an investigator for Allergan plc, participated in an Allergan Juvéderm Volite advisory board, and received research funding for the clinical registration trial of VYC-12L. J Thulesen is a consultant for Allergan plc, participated in an Allergan Juvéderm Volite advisory board, and is a faculty member of the Allergan Medical Institute. The authors report no other conflicts of interest in this work.

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