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Restylane® SkinboostersTM for the improvement of skin quality Results of a consensus meeting

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Schlüsselworte

Summary

Restylane® Skinboosters™ are outstandingly suitable for deep hydration of the skin, and their effect is long-term and safe. Natural treatment results fulfil the needs of the patients and increase the patient-practitioner relation. In the new guidelines on the optimal application of Restylane® Skinboosters™ Vital Light and Vital the indications, application intervals, injection technique and compliance are addressed in detail. Furthermore, illustrated application recommendations (e.g. injection amount, technique, points and volumes) for different target groups and treatment areas such as face, décolleté and hands will provide the practitioner security in handling Restylane® Skinboosters™.

Zusammenfassung


For every woman, beauty plays a significant role in their lives beyond the age 40. With a good constitution and an active lifestyle, women on average feel ten years younger than they are and they want to look as young as they feel. More than half of women define attractiveness through a firm, wrinkle-free skin [7, 18].

 

Study results from Fink et al. Document that a smooth skin texture, therefore fine, tight, full skin without wrinkles, as well as a healthy skin tone with a special glow significantly influences perceived attractiveness. As a result, female attractiveness is assessed higher if the skin shows less blemishes [4, 12, 13]. In our society, youthfulness and beauty are positively attributed and also determine interactions and positioning in the social as well as the professional environment [2, 6, 10, 14, 17]. Therefore, the need for attractiveness is quite understandable. But with increasing age, the quality of the skin changes. Histological studies, for example, show a reduction and incorrect cross-linkage of the elastin fibers and a decreasing hyaluronic acid (HA) synthesis with reduced water binding (50% reduced HA concentration in 60-year-old women) [21]. The reduced number and activity of fibroblasts additionally leads to a reduced collagen synthesis and a decrease of dermal collagen I and III. Visible signs of the intrinsic aging process include dehydration, loss of tissue tightness and elasticity, wrinkle formation as well as a thinning of the skin and can be superimposed by extrinsic skin aging (especially UV-induced photo aging).

 

Minimally invasive aesthetic treatments intended to delay the skins aging process are increasing in demand. Today, patients want an out-patient aesthetic treatment with little side effects and a long-term outcome, leading to effective but also natural results with minimal recovery time. Accordingly, the substitution of HA by means of intradermal injections is an established anti-ageing measure, with proven, evidence-based efficacy and safety.

 

In principle, injectable HA products can be classified into two groups with different therapeutic goals. Whereas HAfillers are used for targeted wrinkle augmentation and volume substitution, skin boosters are injected superficially for the revitalization of the skin. They improve the signs of skin aging through stimulation of the extraellular matrix (ECM) [5, 22, 26]. The biological significance of HA for the skin as well as its excellent physicochemical properties, especially its high water-binding capacity, determine injectable HA based skinboosters for improvement of skin quality. Although native HA is ubiquitous in the human body, the largest amount is located in the skin. With 7-8 g of HA, the skin contains approximately 50-56% of the total body content. HA is a significant stabilizing component of the ECM, can bind large amounts of water and is essential for hydration homeostasis.

Table 1: Product recommendations.

Apart from its significance as a structure substance, HA is also an important functional tissue component, because extracellular substance transport (diffusion of electrolytes, nutrients and decomposition products in the tissue) as well as the activity of the immune system are associated with the hydration status of the ECM. In addition to this, HA is pivotal for cellular processes such as proliferation, differentiation and migration. Amongst other processes, it stimulates fibroblast proliferation and activity with an increased biosynthesis of collagen and other components of the ECM. Apart from regenerative tasks such as improved wound healing under HA, it also has cell protecting properties against external noxious substances. In current studies, it is being discussed whether HA itself fulfills the function of a radical catcher for the deactivation of ROS or whether a reaction with free radicals attacks and leads to it’s destruction [11, 28].

 

The efficacy and safety of the widely applicable Restylane®™ SkinboostersTM are excellently proven on the basis of current data. According to these findings, they ensure an improvement of skin quality without significant volume changes. The skin is hydrated [8, 15, 27], its elasticity increased [8, 15, 16, 20, 23, 27], the skin surface smoothened [8, 16, 20, 27] and fine lines and wrinkles are reduced [16].

 

Restylane® Skinboosters™ are injected subcutaneously and have a clinically proven effect duration of up to 12 months [16]. The long lasting and significant effect is due to the use of non-animal stabilized hyaluronic acid (NASHA), especially in direct comparison with non-stabilized hyaluronic acid. This was proven by a number of studies including Carruthers et al. (2014) as well as Williams et al. (2009) [5, 27]. The substitution leads to a stimulation of fibroblast proliferation and activity with new synthesis of collagen, elastin and other extracellular components such as HA, leading to more skin elasticity, skin tension and moisture [5, 25, 26]. The positive study results are supported by high patient satisfaction. According to blinded live-rating, skin quality improved in more than 80% of the patients. 85% assessed the therapeutic success positively and stated that they would repeat the treatment. Furthermore, patients as well as blinded evaluators indicated significant aesthetic improvements on the basis of the Global Aesthetic Improvement Scale (GAIS).

 

For the standardization of therapy protocols, a consensus meeting with six experts from the field of aesthetic dermatology took place (committee members see Appendix). The objective of the scientific expert committee was the compilation of an updated guideline for the application of Restylane® Skinboosters™. Current evidence-based studies and the expertise of the committee members were included in the new standardized treatment protocols for the various indications, which through clear recommendations (e.g. injection depth, application intervals) are intended to guide novices as well as experienced users towards Restylane® Skinboosters™ and provide support for the application in everyday practice. For the indication-appropriate application, the treatment protocols define the respective treatment area, the target group and indications, the protocol selection and injection amount, technique, points and volumes for every indication.

PRODUCT SELECTION

The target group for Restylane® SkinboostersTM are patients who want an improved skin structure. In the past, the choice for the correct Restylane® Skinboosters™ has been individually made for every patient based on the Glogau Scale (classification of akin aging in skin types I-IV). However, since this classification method is very complex, the Glogau Scale is now being replaced by a simpler system. This updated classification is supposed to help even novices to easily arrive at the correct product selection for their patients. It will also help experienced practitioners improve day- to-day efficiency.

First, the skin in the treatment area should be defined. The new classification differentiates between more mature, thicker, partially light-damaged skin with more covering tissue (Type A skin, e.g. cheeks) and younger, thinner, more sensitive skin with less covering tissue (Type B skin, e.g. neck). For Type A skin, the use of Restylane® SkinboostersTM Vital is suitable with strong tissue coverage and low lifting capacity. For Type B skin, the practitioner can select Restylane® Skinboosters™ Vital Light with low tissue coverage and very low lifting capacity (Table 1). Special challenges could be posed by thick photo-aged skin, mature and thin or sensitive skin, although even younger skin can be associated with less tissue coverage in certain areas. Here, the success of the treatment is closely associated with the expertise of the practitioner, whose patient-individual choices are decisive for treatment results. For example, with an optimal treatment, skin aging symptoms (e.g. dehydration, loss of tissue tightness and elasticity, wrinkle formation, atrophy and photo aging) as well as deep acne scars can be reduced and skin quality can thereby be visibly improved. With UV-damaged skin, a more conservative application of Restylane® Skinboosters™ should be considered. The stronger the skin is damaged through light, the more difficult it is to activate the fibroblasts. In this case, combination treatments or alternative treatments are preferred. Especially with UV-damaged skin, exclusive therapy with laser has been regarded as helpful. However, prior to laser treatment with a fractioned ablative CO2-laser, Angelis and Tretti recommend the injection of stabilized hyaluronic acid [1]. The Restylane® Skinboosters™ stimulate the fibroblasts, which should then respond better to the thermal stimulation of the laser.

Figure 1: Revised treatment protocol for Restylane® Skinboosters™.

Table 2: CONSENSUS – Indication cheeks.

RESTYLANE® SKINBOOSTERS™ INJECTION

On recommendation of the experts and based on the current state of research, the injection of Restylane® SkinboostersTM should generally be performed superficially in the subcutaneous tissue. It is important not to equate Skinboosters treatment with mesotherapy. Whereas with mesotherapy non-stabilised hyaluronic acid and diverse other substances are injected into various skin layers, the efficacy and safety of the Restylane® Skinboosters™, which exclusively contain non-animal stabilised HA, is clinically proven [19, 20, 23, 24, 27] and must be performed in the area of the deep dermis and subcutis.

Unwanted effects and results – apart from local injection-related reactions such as short-term erythemas or hematomas – usually occur due to incorrect treatment, for example by injecting the Skin- boosters too superficially. If Skinboosters are applied too superficially and the skin is too thin, there is a risk for nodules / papules formation and an accumulation of the injected material. This undesirable effect can be prevented with injections into the correct skin layer. Nevertheless, if it occurs the committee recommends the application of the enzyme hyaluronidase. Another safety issue besides the defined injection depth is the selection of a suitable cannula. Depending on the expertise

of the practitioner the injection can be performed with blunt cannulas or with sharp needles. Blunt cannulas are principally associated with lower side-effects and are therefore usually preferred by the patients. Blunt ending cannulas (Pix’L 23G -50 mm to 25 G -40mm) have beenclinically proven to reduce injection-related reactions [3, 9]. With less penetration points and a reduced risk of hematoma formation, patient comfort is increased. Furthermore, the lateral outlet of the cannula ensures a more even distribution of the Skinboosters and the treat- ment is experienced as being less painful. Through the optional SmartClick™ System, application safety can additionally be increased: for each 10 μl injected, a click is triggered, enabling the practitioner to completely focus on the injection and attend to the patient while the product is evenly delivered.

For an indication-conforming application, the injection amount, technique, points and volumes are recommended in the treatment protocols for the respective treatment area (Tables 2-5, Figure 2).

APPLICATION INTERVALS

So far, the treatment regimen for Resty- lane® Skinboosters™ recommends three build-up treatments at an interval of four weeks and two repeated treatments after six months respectively. As Restylane® Skinboosters™ are medicinal products, deviations can be made from the described treatment scheme in clinical practice if safety is ensured.

Figure 2 : CONSENSUS – Restylane® SkinboostersTM Volume per Indication.

Results from current studies and the experience of the experts suggest a reorientation in the recommendation on application intervals. The expert committee agreed that two applications lead to very good results and a current investigation from Kerscher et al. substantiates this [19]. The new treatment protocol (Figure 1) recommends two, optionally three ini- tial treatments at an interval of respectively four weeks. In everyday practice however, patient-individual decisions are recommendable: for patients who wish for less treatments, longer intervals can be planned between the appointments. Although a few days after the first treatment an increasing amount of water is bound in the patient’s skin and a visible effect is achieved, only repetitive treatment can stimulate the fibroblasts and instigate a collagen biosynthesis. For high patient satisfaction and a long- term relationship to the treating physician patient education is paramount, especially regarding the expectations towards the delayed occurring effect. Fur- thermore, the revised treatment protocol is based on current research on the effect duration of the Restylane® Skinboosters™: for Restylane® Skinboosters™ Vital Light [24] a duration of the aesthetic effect of nine months was substantiated,

for Restylane Skinbooster Vital even up to 12 months [16]. Subsequent to the two to three initial treatments, two repeated treatments are only recommended after respectively 9-12 months (figure 1).

Table 3: CONSENSUS – Indication perioral (smoker’s lines).

Table 4: CONSENSUS – Indication Décolletage.

TREATMENT PROTOCOLS FOR FACE, DÉCOLLETAGE AND HANDS

CONSENSUS – FACE

Indication cheek / indication periorbital (crow‘s feet):
The indication cheek includes the upper and the lower cheek area. The indication periorbital (crow‘s feet) is allocated to the treatment area „upper cheek“ (Table 2). Indication perioral (smoker’s wrinkles): (Table 3)

CONSENSUS – indication Décolletage

(Table 4)

CONSENSUS – Indication hands

(Table 5)

The indications forehead, temples and neck are expert indications for Restylane® SkinboostersTM treatment. Therefor no recommendations are given in this consensus.

Table 5: Consensus – Indication hands.

SUMMARY

Restylane® Skinboosters™ are outstandingly suitable for deep hydration of the skin, and their effect is long-term and safe. Natural treatment results fulfil the needs of the patients and increase the patient-practitioner relation. In the new guidelines on the optimal application of Restylane® Skinboosters™ Vital Light and Vital the indications, application intervals, injection technique and compliance are addressed in detail. Furthermore, illustrated application recommendations (e.g. injection amount, technique, points and volumes) for different target groups and treatment areas such as face, décolleté and hands will provide the practitioner security in handling Restylane® Skinboosters™.

 

Address of Correspondence

Conflict of Interests

The consensus meeting was supported by Galderma Laboratorium GmbH (Düsseldorf, Germany).

References

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