SUNEKOS INJECTABLE AND THE HIGH PERFORMANCE TECHNIQUE COUNTERACTING SKIN AGEING

Dr Elena Fasola details an injection technique to combat wrinkles, skin laxity, and photoaging dyschromia

ABSTRACT

The increase in life expectancy, together with the impact of the recent Covid-19 pandemic, which has been associated with long video conferencing sessions, has seen an increase in the demand for minimally invasive procedures aiming at improving people’s appearance. One of the most important pathophysiological aspects which underlies skin ageing is the loss of the extracellular matrix (ECM) homeostasis. The main reasons are the reduction of fibroblast activity, the reduction of their number and a down regulation of their membrane receptors, in quantitative and qualitative terms. This condition, related to ageing, causes a decrease and change in composition of the main macromolecules of which the ECM (collagen, elastin and hyaluronic acid) with consequences on homeostasis of ECM and skin health.

Thanks to the use of the patented HY6AA formula, two products, one based on low molecular weight hyaluronic acid (SuneKOS Performa) and the other with a high molecular weight hyaluronic acid (SuneKOS 1200) both added to a specific six amino-acids formula delivered by a new technique, named High Performance Technique (HPT), it is possible to counteract the complex process of skin ageing in a relatively short time through a minimally invasive treatment, achieving very interesting results in both sexes.

KEYWORDS

High Molecular Weight HA, Sunekos, High Performance

Technique Skin ageing

WITH THE COVID-19 PANDEMIC, THE NUMBER OF PEOPLE working from home and meeting online has markedly increased. Almost everyone, for personal or business reasons, increased the time spent on video calls, leading to the socalled ‘Zoom Boom’. Psychologically, this led and resulted in an increased demand for cosmetic facial surgeries. Due to the impact of COVID-19, there is an expected 51% increase in demand for facial injectables. As in all other fields, minimally invasive surgeries are replacing invasive surgeries. In the US, nearly 15.6M cosmetic surgical procedures were performed in 2020, out of which nearly 13.2M were minimally invasive. Minimally invasive surgeries drive market growth for two reasons: patient preference and the wide range of available treatment options. In 2021 the global facial injectable market size was estimated to be $16.1 B. The compound annual growth rate (CAGR) for the years from 2022 to 2030 is 9.1%1

Skin ageing

Microscopically, one of the most important pathophysiological aspects of ageing is the loss of the extracellular matrix (ECM) homeostasis. One of the leading causes for this is the reduction of fibroblasts, both in quantitative and qualitative terms, causing a decrease in collagen and elastin. Another key factor is hydration loss.

Ageing determines not only a noticeable reduction in total skin collagen but also a change in composition. Indeed, every type of collagen has distinct relevance and role in the tissues.

First of all, type III collagen makes up 50% of the collagen in the dermis of neonatal skin but only 5% of the collagen in adult ageing skin. It supports the structure of hollow organs such as large blood vessels, the uterus and the intestines. It is found in other tissue (e.g. dermis) along with collagen type 12. On the other hand, type IV collagen anchor plates between different types of fibrils. It decreases with age after 35 years. Although type IV collagen is a basement membrane component and declines with ageing, the total thickness of this membrane increases, which suggests a reduction in tissue turnover3 Therefore, we can conclude that ageing determines not only a noticeable reduction in total skin collagen but also a change in its composition.

Ageing is characterised by an increase in elastin degradation; this is due both to increased matrix metalloproteinases (MMP) and decreased elastin production.

Besides collagen, at a microscopical level, many other molecules and components are of key importance. First of all, elastin is a protein able to stretch and contract. It is produced by the fibroblasts of the dermis. In quantitative terms, it represents 2% of the weight of the dermis, secreted in the form of a monomer (tropoelastin). It contributes together with the fibrillin microfibrils to form a three-dimensional network. Concluding, it confers elasticity to the skin.

Ageing is characterised by an increase in elastin degradation; this is due both to increased matrix metalloproteinases (MMP) and decreased elastin production4

Fibronectin, on the other hand, is a dimeric glycoprotein produced by many cells and tissues, present in connective tissue. Fibronectin plays a major role in cell adhesion and in anchoring reticular collagen fibres and cells. Many homologous molecules able to bind together the components of the extracellular matrix are derived from fibronectin. With ageing, fibronectin decreases.

Hyaluronic acid (HA) is a key component of the skin at a microscopical level. Depending on its molecular weight, its properties differ.

Low molecular weight HA (LMWHA) up to 200 kDa regulates homeostasis. This is due to its capability of water retention, which also hydrates the skin.

Moreover, stimulating fibroblasts, it promotes the synthesis of dermis structural elements (collagen, elastin and blood vessels). It also has an immunomodulatory effect.

On the other hand, high molecular weight HA (HMWHA) 1000–1500 kDa acts as an antioxidant. It has anti-inflammatory properties and, acting as a ROS ‘scavenger’, it protects fibroblasts and dermal structural elements.

Any decrease in hyaluronic acid directly causes a reduction in fibroblast activity, as well as down-regulation of CD44, RHAMM receptors and gene-transcriptors for HA. Moreover, ageing is also characterised by a hyaluronidase increase, causing direct hyaluronic acid destruction5

Macroscopically, ageing is characterised by wrinkles, laxity, and dyschromia. The rationale behind counteracting ageing is based on restoring the ECM.

Langer’s lines, also called Langer lines of skin tension or cleavage lines, are topological lines drawn on a map of the human body. They are parallel to the natural orientation of collagen fibres in the dermis and generally perpendicular to the underlying muscle fibres (Figure 1). Langer’s lines have relevance to forensic science and the development of surgical techniques6. The lines were first discovered by Austrian anatomist Karl Langer in 1861. They may be, more easily, defined as folding lines upon which skin falls during the ageing process7–8

Can we counteract skin ageing?

Cutaneous facial ageing can be counteracted by using a protocol combining two products; both consist of a specific formula based on non-cross-linked hyaluronic acid of different molecular weights, added to a pool of 6 amino acids (HY6AA Formula). These two products are the following:

■ Sunekos 1200 containing high molecular weight hyaluronic acid (HMWHA 1200 kDa) and a mix of 6 amino-acids (glycine, L-proline, L-lysine MHC, L-leucine, L-valine, L-alanine) (HY6AA formula) may act as a ROS ‘scavenger’, protecting the fibroblasts and the ECM. Due to its hygroscopic properties, it performs a re-hydrating action.

■ Sunekos Performa (HY6AA formula) contains low molecular weight hyaluronic acid (LMWHA 200 kDa) and a specific mix of 6 amino-acids (glycine, L- proline, L-lysine MHC, L-leucine, L-valine, L-alanine) in a 3.5 ml of premixed solution.

Performa contains the HY6AA formula in a new ratio of HA vs amino acids. This formula improves the stimulation of collagen production (mainly type 4 and 7) and elastin by reducing the hyaluronidase action by 40%, therefore increasing the longevity and the effect of the injected HA, an endogenous one, to support an improved ECM turnover. Moreover, low molecular weight HA helps to regulate the microcirculation with the overall result of restoring homeostasis of the ECM9

In an in vitro study, cultured human fibroblasts were exposed to an HY6AA formula and controlled with untreated tissues. Both groups were then compared and analysed 72 hours after. Treated fibroblasts showed significantly increased elastin (Eln) and fibronectin (Fbn1) mRNA levels. In this way, oxidative stress decreases together with UV exposure damage.

In conclusion, the HY6AA formula appears to restore the ECM’s homeostasis in ageing through an accurate and precise process of stabilisation and stimulation of multiple molecules10

In an ongoing observational pilot study, 50 female patients were enrolled, ranging from 40 to 67 years of age. Patients underwent three sessions of treatment at 14-day intervals. At each visit, 3.5 ml of the HY6AA formula was injected.

From preliminary analysis, the treatment with HY6AA formula resulted in improved elasticity, improvement in wrinkle appearance and a reduction in photoaging dyschromia.

Amelioration regarding elasticity was tested with a pinching test. Visia skin analysis was used for the analysis of wrinkle reduction, and we observed a 44% decrease in wrinkles in the periocular area and a 71% decrease in the forehead.

With regard to skin pigmentation related to ageing, a 50% decrease was observed in rosacea, a 49% decrease in photoaging dyschromia, and a 40% decrease in general chromatic inequalities11

Full-face high-performance technique Indication

To counteract all aspects of the complex skin ageing process, which include both chronic and photo ageing. The specific indications are wrinkles, skin laxity, and photoaging dyschromia.

Protocol

The treatment protocol is carried out as follows (Figure 2). During the first treatment session, both products are injected, firstly Sunekos 1200 and immediately followed by Sunekos Performa. After an interval of 14 days (2 weeks), only Sunekos Performa is injected again. Finally, after a further 14 days, the last injection of Sunekos Performa is delivered. In some particularly pronounced cases of chrono and photo-ageing, a fourth injection of Sunekos Performa may be required.

Technique

The injection technique for Sunekos 1200 can be summarised as follows (Figure 3).

The injection with Sunekos 1200 is performed with either a 25G or 27G cannula or a 27G or 30 G needle. The choice of the cannula by the doctor depends on the quality and thickness of the patient’s skin. The entry point of the cannula is located about halfway along the longitudinal axis of the nasolabial fold, the cannula is inserted to 2 cm of its length, and the product is released into the subdermal layer in quantities up to a maximum of 0.6 ml (from 0.3 to 0.6 ml) with a retrograde technique. Using the same entry point as the cannula, the product is deposited at a second identified point at the junction between the hemi-pupillary line and a line drawn between the tragus and the wing of the nose. In this second point, 0.3 ml of product is deposited with the bolus technique in the same subdermal plane where the cannula is located.

The third point of product deposit is identified halfway between the vertical line that passes from the labial chant and the median line of the face. At this point, 0.3 ml of product is injected with a 27 G or 30 G needle into the deep dermis with a bolus technique. Depending on the condition of the chrono- and photo-ageing of the patient, other optional points may be considered for treatment (Figure 3).

The injection of Sunekos Performa consists of multiple injections of small product boluses (0.1 ml per bolus), all injected into the medium/deep dermis with a 27G–30G–32G needle, following lines orthogonal to the Langer lines of the face (Figure 4).

B

Per hemiface, the first three injections are performed at about 1.5-2 cm from each other along a line drawn between the tragus and the wing of the nose. Another five injections are performed with the same distance between them. The first four injections are performed along another line that passes between the tragus and the chin protuberance, the fifth immediately below the chin, at the level of the chin guard spine, always in the middle/deep dermis. Three more injections are performed about 1.5 cm between them and 1.5 cm above and along the profile of the body of the mandible.

The treatment session is completed through another six injections per each side of the face. At the level of the forehead, the injections are made at a distance of about 1.5 cm between them along three lines placed in a fan or triangle (whose angle is located on the hemi-pupillary line at 1.5 cm from the roof of the orbit) and orthogonal to the Langer lines. Also, in this case, the amount of product injected per bolus is 0.1 ml.

Contraindications

The contraindications to the treatment are not dissimilar to other hyaluronic acid-based injectable products:

■ Presumed or confirmed sensitivity towards one of the contents or ingredients of the product

■ Ongoing inflammatory or infectious diseases affecting the treatment area

■ Ongoing anti-inflammatory/anti-coagulant therapy, or patients affected by coagulation factor disorders

There are no known overdose events as well as unwanted adverse events, but the author recommends not to use the products in patients:

■ with non-absorbable facial filler,

■ treated with botulinum toxin within a short period of time or in the same session or the same area of injection of Sunekos

■ treated with cross-linked HA filler in the same area, at the same time and in the same plane as the Sunekos injections.

As observed for now, the only secondary effects were redness at the injection site, slight swelling and, rarely, small ecchymosis. Symptoms, on the other hand, were described as a slight burning sensation (immediately after the injection) and a feeling of warmth, which spontaneously disappeared in about 1 hour.

Results

The improvement of signs of chrono and photo-ageing obtained using the full-face HPT (High-Performance Technique) with the combined protocol of the two products (Sunekos 1200 + Sunekos Performa) are evident in both the female and male sex (Figures 5 and 6).

Conclusions

The injection of these two products, Sunekos 1200 and Sunekos Performa, allows us to face and counteract skin ageing in a transversal way:

■ Thanks to their different composition (different molecular weights of hyaluronic acid and different proportions of the amino acids), they perform two different and complementary actions: the first product re-hydrates the deep dermis and adds an anti-free radical effect, while the other regenerates the extracellular matrix.

■ The products are injected into two different dermal layers, one subdermal with a cannula and the other intradermal with a needle treating the tissue to full thickness.

The dermis is treated following orthogonal lines to the Langer lines to enhance the traction forces perpendicular to the skin laxity lines.

Declaration of interest Funding for this research was provided by Professional Dietetics

Key points

One of the most important pathophysiological aspects which underlies skin ageing is the loss of the extra-cellular matrix (ECM) homeostasis.

The condition can be treated with two products using a patented HY6AA formula, one based on low molecular weight hyaluronic acid (SuneKOS Performa) and the other with a high molecular weight hyaluronic acid (SuneKOS 1200) both added to a specific six amino-acids formula

Delivered via a new technique called the High Performance Technique (HPT), it is possible to counteract the complex process of skin ageing in a relatively short time through a minimally invasive treatment

References

1. Facial Injectable Market Size, Share & Trends Analysis Report By Product (Collagen, Hyaluronic Acid, Botulinum Toxin Type A, Calcium Hydroxylapatite, Polymer Fillers), By Application (Aesthetic, Therapeutic), By Region, And Segment Forecasts 2022–2030

Published Date: Apr, 2022

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3. F.Vasquez et al. Changes of the basement membrane and type IV collagen in human skin during ageing. Maturitas. 1996 Nov

4. Characteristic of the Ageing Skin. Advances in wound Care. February 2013

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6. Method and apparatus for determining the lines of optimal direction for surgical cuts in the human skin. US Patent 6418339. Archived from the original on 2013-04-21.

7. Karl Langer, ‘Zur Anatomie und Physiologie der Haut. Über die Spaltbarkeit der Cutis’. Sitzungsbericht der Mathematischnaturwissenschaftlichen Classe der Wiener Kaiserlichen Academie der Wissenschaften Abt. 44 (1861)

8. Langer, K (January 1978). “On the anatomy and physiology of the skin”. British Journal of Plastic Surgery. 31 (1): 3–8. doi:10.1016/0007-1226(78)90003-6. PMID 342028.

9. B. De Servi A. Orlandini E. Caviola – M. Meloni . Amino acid and hyaluronic acid mixtures differentially regulate extra cellular matrix genes in cultured human fibroblasts. Biol Regul. Homeost Agents. May-Jun 2018; 32(3):517-527. PMID: 29921376

10. Laura Tedesco. A designer mixture of six amino acids promotes the extracellular matrix gene expression in cultured human fibroblasts. Bioscience, Biotechnology, and Biochemistry, 2022, Vol. 86, No. 9, 1255-1261

11. E. Fasola, E.A. Kutera. Pilot Study evaluating the therapeutic effects of a new pre-mixed injectable product of low molecular weight (LMW) hyaluronic acid added to six amino acids (HY6AA + Formula) in facial skin aging. JDC, August 2022