A Personalized Protocol for Facial Rejuvenation Using Two... : Plastic and Aesthetic Nursing (2024)

The current trend in aesthetic medicine requires that aesthetic practitioners use minimally invasive and safe treatments to target individual areas of concern and promote global facial tissue restoration (^{La Gatta et al., 2016a,2020}). Aesthetic practitioners can use several treatments (each formulated for a unique purpose) to target different areas of the face simultaneously (^{La Gatta et al., 2016a; Sundaram & Cassuto, 2013}).

Based on their effectiveness and their high safety profile, cross-linked hyaluronic acid (HA)-based fillers (i.e., where the HA molecules are combined with a collagen membrane to slow resorption and extend effect) are widely used to achieve patients’ desired aesthetic outcomes (^{La Gatta et al., 2020; Sundaram & Cassuto, 2013}). In the Aliaxin^® line of soft tissue facial fillers, commercialized by IBSA Farmaceutici Italia Srl, each formulation is designed to target different facial tissues and areas of concern. This product line contains six formulations:

• Aliaxin^® Shape and Restore (A_SR)
• Aliaxin^® Global Performance (A_GP)
• Aliaxin^® Essential Volume (A_EV)
• Aliaxin^® Superior Volume (A_SV)
• Aliaxin^® Fine Lines (A_FL)
• Aliaxin^® Lips Volume (A_LV)

Aliaxin^® products are 1,4-butanediol diglycidyl ether-cross-linked HA hydrogels, each with a different combination of HA molecular weights (MWs) (^{La Gatta et al., 2016a}). HA polymers of different MWs display several activities. When the MW is below 5 kDa (a measure of molecular mass), the molecules promote proinflammatory activity. When the MW is above 200 kDa, the molecules promote anti-inflammatory activities (^{Lee et al., 2021}). The MW of Aliaxin^® cross-linked HA fillers is medium-high and promotes anti-inflammatory activity (^{Lee et al., 2021}). In addition to its anti-inflammatory properties, the selection and combination of different MW polymers in the Aliaxin^® fillers allow aesthetic practitioners to use products with varying viscoelastic properties (^{La Gatta et al., 2016a}). Medium MW HA (i.e., 200–500 kDa) contain shorter polymer chains that tend to form fewer chemical interactions between HA polymers. These interactions create the capacity for increased water retention, and thus provide a high hydration ability when used in a clinical setting (^{La Gatta et al., 2020}). Alternatively, high MW HA (≥1,000 kDa) contain a higher entanglement of HA polymer chains, increasing the mechanical properties of the fillers, while reducing their water retention and hydration abilities (^{La Gatta et al., 2020; Lee et al., 2021}). A_SR is a combination of HA containing three HA MWs (500, 1,000, and 2,000 kDa) to provide high hydration and gentle lifting (^{La Gatta et al., 2016a}). A_GP contains a combination of 1,000 and 2,000 kDa HA and because of its mechanical properties, is better suited for targeting deep folds and wrinkles (^{La Gatta et al., 2016a; Aliaxin® GP Package insert, 2019}).

Besides HA MW, differences in crosslinking methods and HA concentration also alter the rheological properties of each product (i.e., the way that materials deform or flow in response to applied forces or stresses), directly impacting the recommended injection technique and application site (^{Cassuto et al., 2021; Edsman et al., 2012; La Gatta et al., 2016a,2016b,2020; Stocks et al., 2011; Sundaram & Cassuto, 2013}).

The ability of a filler to integrate into the surrounding tissue is important for creating a natural result. Products with lower elastic properties (i.e., ability of a material to return to its original shape and size) and higher deformability (i.e., ability of a material to change its shape or size under the influence of an external or internal force), spread more effectively within the tissues. These properties are indicated by a lower G prime (G′) (i.e., a value that measures the elastic modulus of a filler [i.e., the ability of the gel to return to its original shape when subjected to dynamic forces]) (^{La Gatta et al., 2016a; La Gatta et al., 2020; Stocks et al., 2011}).

Products with a high G′ (≥200) are able to create more structural support and volume/projection and penetrate deeper into tissues than products with a low G′ (^{La Gatta et al., 2016a; La Gatta et al., 2020; Stocks et al., 2011}). Previous rheological studies have demonstrated that A_SR has the lowest G′ (equivalent to 39) and is also the least rigid and viscous product, which is consistent with lower levels of crosslinking (^{La Gatta et al., 2016a; La Gatta et al., 2020}). A_GP has a higher G′ (equal to 95) and is more rigid, viscoelastic, and viscous compared with A_SR (^{La Gatta et al., 2016a; La Gatta et al., 2020}).

All fillers from the Aliaxin^® product line, including A_SR and A_GP, are also reported as fully cohesive according to the Gavard–Sundaram Cohesivity Scale, meaning that the optimal integrity of these fillers once injected is maintained without unwanted gel migration (^{La Gatta et al., 2020; Sundaram et al., 2015}).

To choose the best product for the target area and personalize the patient’s treatment for each area of concern and aesthetic expectation, it is fundamental that aesthetic practitioners understand the characteristics of HA-based fillers. Evaluating the experimental metrics used to assess the fillers’ G′ and tan delta (which quantifies the gel flowability or its ability to remain at the injection site or to spread into surrounding tissues) is also essential when comparing products with varying rheological properties. These metrics may vary significantly depending on the mechanical forces and temperatures employed to test them, which makes comparing products from different companies difficult or impossible. To maximize product spread and target specific soft tissues, aesthetic practitioners should use tailored injection sites and techniques for each product. The following retrospective case series discusses our treatment of four patients using two different Aliaxin^® fillers, to achieve harmony and correct missing facial volume. The rheological characteristics and MW of the fillers used in this retrospective case series are reported in Table 1.

MATERIALS AND METHODS

Patients and Eligibility Criteria

For this retrospective case series, we assessed four selected patients between 35 and 55years. We excluded patients with a known hypersensitivity reaction to HA and patients with any pathology or dermatologic condition in the target areas. We also excluded pregnant or breastfeeding women and women who had already received a treatment in the same area 6months earlier. We obtained informed consent, and all patients agreed to participate in this case series and to allow us to use their images for scientific research.

Treatment and Injection Procedures

We treated all patients with A_SR or A_GP according to their anatomical characteristics and needs. Patient 1 was treated with A_SR; patients 2 and 3 were treated with A_GP; and patient 4 was treated with a combination of A_SR and A_GP.

As shown in Figure 1A, the A_SR injection procedure requires two injection points. The first entry point is at the zygomatic-temporal border. We used a 25 G × 50 mm cannula and retrograde injection with a z- or t-fanning technique. The second entry point is at the anterior border of the masseter with entry from the mandibular line. We again used a 25 G × 50 mm cannula and a retrograde injection with fanning. We used 1 mL of A_SR for each treated area on both sides of the face.

As shown in Figure 1B, we applied the A_GP injection to the mid-lower third of the face using two injection points. The first entry point was 1 cm from each side of the corner of the mouth. We used a 25 G × 38 mm cannula to inject 0.8 mL of A_GP, with 2–3 passages of a retrograde subdermal injection and a fanning technique to treat nasolabial folds. Notably, when patients present with fat pad atrophy, cheek flattening, thin skin, or a lack of volume in the periocular area, the practitioner should also treat the mid-face. Practitioners can target the deep fat pad by using a fanning retrograde injection technique 1.5 cm below the maximum zygomatic projection using a 25 G × 38 mm cannula and 1 mL of A_GP for each side of the face.

As shown in Figure 1C, when using both A_SR and A_GP, we injected 1 mL A_SR at the zygomatic-temporal border, 1 mL at the anterior border of the masseter, and 0.8 mL A_GP in the nasolabial folds on each side of the face.

Clinical Assessment

We performed clinical assessments using observation and 2-dimensional camera pictures. We also evaluated all patients immediately after treatment using a Visual Analog Scale (VAS). Using the Global Aesthetic Improvement Scale (GAIS), both the investigators (GAIS-I) and patients (GAIS-P) provided a rating score:

• immediately after injection (D0),
• 90days (3months) after injection (D90), and
• 180days (6months) after injection (D180)

We also evaluated the patients’ tolerability and general safety of the treatments throughout the duration of the clinical evaluation.

RESULTS

Clinical Assessment

Patient 1

Figure 2 shows photographic images of a 47-year-old woman before and after treatment with A_SR. There was a clear improvement in skin texture and an increase in skin elasticity. Gentle stretching of the zygomatic area increased zygomatic projection, improved the definition of the malar area, and reduced the patient’s periocular wrinkles. Additionally, the patient experienced an improved definition of the mandibular angle and jawline and an improvement of the nasolabial folds. Overall, the face appeared softer, and any asymmetry was corrected.

Patients 2 and 3

We treated patient 2 (55years old) and patient 3 (39years old) with A_GP injected in the mid and lower third of the face. The treatment provided a natural volume and harmonization within the zygomatic area, along with a good improvement in volume in the tear trough area and jawline (Figures 3 and 4). Moreover, the nasolabial folds and marionette lines were visibly reduced in both patients. Patient 2 also experienced a marked decrease of periocular wrinkles. The overall effect of the treatment was a soft harmonizing enhancement with general facial volume restoration.

Patient 4

Figure 5 shows photographic images of a 50-year-old woman before and after treatment with both A_SR and A_GP. We used the A_GP on the lower-third of the face only. The treatment provided an effective softening of severe nasolabial folds and marionette lines, along with a clear improvement in skin tone and firmness. There was also a clear reduction in the patient’s periocular wrinkles and an improvement in the appearance of the eyelids, tear troughs, and jawline definition. The overall effect of the combined treatments was a gentle stretching of the facial profile and harmonized facial uniformity, with soft shaping due to facial volume restoration.

VAS and GAIS Evaluation Results

Using the VAS immediately after the injections, all patients reported mild pain (1-2 out of 10). As shown in Table 2, three patients reported a VAS score of 1, and one patient reported a VAS score of 2.

The investigators (GAIS-I) evaluated all patients as improved or much improved. At D0, the investigators reported an improvement in all patients. At 3 and 6months after treatment (D90 and D180, respectively), two patients were scored as improved, and two patients were scored as much improved (Table 2).

After self-evaluation, the patients (GAIS-P) confirmed the evaluation scores performed by investigators. Immediately after treatment, three of the patients evaluated their general appearance as much improved and one patient evaluated their general appearance as improved. At D90, all patients reported to be much improved. At D180, three patients evaluated their general appearance as much improved, and one patient evaluated their general appearance as improved (see Table 2).

All patients evaluated the tolerability of the treatment as good. There were no unexpected adverse events reported during the clinical evaluation.

DISCUSSION AND CONCLUSIONS

These selected cases demonstrate the use of A_SR and A_GP using protocols tailored to the product’s biophysical properties, and the patient’s areas of concern. Each product and protocol provided effective results based on the investigators’ clinical assessment and were further confirmed by the excellent self-evaluation performed by the treated patients.

All patients and investigators rated the patients’ general appearance as improved or much improved. Importantly, this evaluation occurred not only immediately after injection but also 3 and 6months after treatment, confirming the medium- to long-term duration of these fillers.

Moreover, this retrospective case series also confirms the optimal safety profile of the Aliaxin^® product line, consistent with previously published data (^{Ribé, 2023; Sparavigna et al., 2018; Zazzaron & Musella, 2020}). Evaluating product efficacy and safety is fundamental to the overall treatment success. Although fillers with high G′ values are often used by practitioners to ensure long-term durability (i.e., ≥1 year), it is also important to note that these products could also lead to increased number of unexpected adverse events such as nodules or granulomas (^{Lemperle et al., 2009}).

The results of our study showed that in terms of clinical efficacy, durability, and safety, aesthetic practitioners can achieve excellent clinical outcomes using low–medium G′ fillers such as A_SR and A_GP. The findings of this retrospective case may be limited by the small sample size of patients analyzed. For this reason, further data should be collected with a larger cohort of patients treated with A_SR and A_GP. Despite the limitations of this retrospective case series, these results are consistent with previous clinical experiences with the Aliaxin^® line that showed high patient satisfaction and a good safety profile when using multiple treatments for complete facial restoration (^{La Gatta et al., 2020}). In addition to the physical effects of improving skin hydration and volume, injections of HA have been shown to restore the production of collagen and elastin (^{Bukhari et al., 2018}; La Gatta et al., 2016a; ^{Landau & Fagien, 2015; Mochizuki et al., 2018; Quan et al., 2013}).

A_SR is a highly deformable product that is better suited to superficial placement to maximize product spread (^{La Gatta et al., 2020}). The protocol used for A_SR is designed to optimize the spread of the dermal filler within the facial tissues, prioritizing patients’ skin quality and overall appearance. Treating a patient with A_SR provides a gentle or soft effect that promotes a full but supple appearance. This protocol can be used for patients who display a discrepancy between the temporal fossa and zygomatic projections. The treatment can also induce posterior lifting, which can lighten the weight of sagging tissues on the mandibular ligament.

In contrast, A_GP can be placed deeper into the superficial fat pad, as due to its higher G′, it is able to maintain its structure, allowing the A_GP to create support and lift (^{La Gatta et al., 2020}). Treating a patient with A_GP provides an overall harmonization across the appearance of the face, resulting in a soft volume enhancement.

The protocols described in this study can be used for patients who seek a natural facial enhancement, such as soft shaping or lifting of the face. A_GP can be applied to the lower third or mid-face through two injection entry points. Likewise, aesthetic practitioners can treat the lower third of the face in patients with superficial fat pad atrophy, lack of lateral projection, subdermal atrophy, nasolabial folds, and marionette lines.

The efficacy of treating a patient with both A_SR and A_GP supports the use of multiple products in clinical practice to target whole facial tissue restoration (^{La Gatta et al., 2020}). Utilizing A_SR and A_GP simultaneously promotes global facial improvement, targeted support, lift, and volume, and soft facial fullness. A combination approach can provide a very natural aesthetic, especially in patients with multiple areas of concern. Future studies are warranted to provide additional insights into the use of combined protocols for full facial tissue restoration.

In conclusion, this retrospective case series demonstrated the success of two approaches using Aliaxin^® low–medium G′ fillers to address specific patient needs and provide a natural aesthetic improvement.

ACKNOWLEDGMENTS

Medical writing support was provided by Anna Sanniti, PhD.

REFERENCES