Case Study: Injectable Correction of Dark Circles, Wrinkles and Bags

The aesthetics of the area around the eyes is very important, since the perception of fatigue and age of a person mainly depends on its condition. Wrinkles, bags and dark circles under the eyes can appear even at a young age, and therefore correction infraorbital zone– a popular request of patients of aesthetic clinics.

Adel Sparavigna – dermatologist, scientific and clinical coordinator of SUNEKOS in the article estet-portal.com gives recommendations to combat the signs of aging and presents the results of a study on the aesthetic effectiveness of SUNEKOS® 200 around the eyes. The technique of drug administration was developed taking into account the difference between the movable and immovable parts of the eyelids. 

• Causes of dark circles and bags in the infraorbital area
• Injectables for dark circles and bags under the eyes
• Anatomical features of the periorbital region and filler injection techniques
• SUNEKOS® Injection Aesthetic Efficacy Study; 200 to the area aroundcorner of the eye

Causes of dark circles and bags in the infraorbital region

Dark circles – the main external sign of aging of the infraorbital zone. The appearance of the skin is highly dependent on the state of the circular muscle of the eye and blood vessels. With age, changes in this area are much more noticeable compared to the rest of the skin of the face.

The thin and slightly transparent skin of the eyelid almost does not hide the protruding soft tissue of the middle third of the face, including the powerful subcutaneous vascular system and the circular muscle of the eye. As a result, the surface of the skin looks darker. 

Moreover, fluid can accumulate in the soft tissues around the eye, which leads to swelling eyelids— so-called "bags". Bags under the eyes may increase due to the protrusion of adipose tissue from the orbit. 

Among age-related anatomical changes in soft tissues: 

• subcutaneous fat atrophy;
• loss of volume in the zygomatic region;
• hypertrophy of the orbicular muscle of the eyefor; pseudo protrusion of connective and adipose tissue under this muscle. 
Injectables for dark circles and bags under the eyes

The peculiarities of the skin and the anatomical structure of the area around the eyes require the use of special preparations for its rejuvenation. Applying a conventional filler in this area can be very difficult and lead to accumulation of misplaced drug. 

A truly advanced solution for the eye area –

The use of hyaluronic acid together with the targeting of the extracellular matrix (ECM)

, since it is based on the physiological bioregeneration of the skin and stimulates the formation of new collagen and elastin fibers. 

SUNEKOS® injectable preparation; 200

(Professional Dietetics, Milan, Italy), exclusively presented by DMK Ukraine, provides: 

VCM targeting;

• physiological stimulation of collagen and elastin synthesis due to low molecular weight HA and patented cluster amino acids. 
Due to significant diffusion and the correct composition of the formula, the drug has a high allowable dose

and provides the proper aesthetic effect.  Anatomical features of the periorbital region and filler injection techniques

Because the skin around the eyes is difficult to work with, a

extensive knowledge of facial anatomy

is required for proper drug administration (Fig. 1). Both centuries can be divided into two parts – movable and fixed. 

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The movable part

 of the skin is very thin, and the filler must be injected very shallowly, since this area lies on the orbital septum (zone A in  fig. 1). Adipose tissue with low vascularity is located directly above the orbital septum. Any drug injected into this area tends to accumulate and is heavily washed out by the circulatory system. 

The fixed part

 of the eyelid lies on the orbital septum, adipose tissue, muscle and bone. Age-related changes in the middle third of face lead to a relative deepening of the orbital ridge and loss of volume in the region of midfacial and zygomatic bones, which causes tension in the orbital and facial supporting ligaments.  

 

As the fatty pads sink and reduce their volume relatively inflexible ligaments lead to fixation and the associated retraction of the eye-socket and "sagging" appearance of the face. Emerging cavities contribute to the increased formation of shadows, especially noticeable in the region of the lacrimal sulcus in the middle third of the face. 

The proposed correction technique

 is designed to take into account the difference between the movable and fixed parts of the eyelids: 

into the movable part
• , injections are made using a superficial linear retrograde technique (Fig. 2A): The 30G needle must be inserted parallel to the skin surface so that it is visible during the process, and the drug is injected in a small amount ;
into the fixed part
• , the drug is injected as a bolus of 0.2 ml directly onto the underlying bone surface: a 30G needle is inserted perpendicular to the skin surface, touching the bone and the drug is injected (Fig. 2B). 

Fig. 1. Anatomy of the periorbital region:

Zone A: 

Rubrow fat pack (ROOF)
Orbicular muscle of the eye
Pre-aponeurotic adipose tissue
• Orbital septum
Superior muscle of the cartilage of the eyelid
Aponeurosis of the elevator muscle
Capsulopalpebral fascia (CPF)
Inferior muscle of the cartilage of the eyelid
• Orbital septum
Adipose tissue of the orbit

Zone B:

Orbicular muscle of the eye
Adipose tissue under the orbicular muscle of the eye (
• SOOF)

Zone A – inject the drug parallel to the skin and very shallow; enter on green lines at one or two points;

Zone B – insert perpendicularly until it touches the bone.          

Half ampoule on each side of the face, 0.1 ml per spot.

 

Fig. 2 (A) Into the movable part of the area around the eye, the drug is injected using a superficial linear retrograde technique. (B) When inserted into the immobile part of the periorbital region, the 30G needle is inserted perpendicular tobut the skin surface to the bone surface and the drug is injected.  Aesthetic efficacy study of SUNEKOS® injections; 200 to the area around the eyes 

Purpose of the study
•  
The main goal of the study – evaluate, using clinical methods and non-invasive instrumental measurements

, the aesthetic effectiveness of SUNEKOS® injections; 200

around the eyes. An experienced dermatologist performed three microinjection treatments using subdermal and periosteal injection techniques; the interval between sessions was 15 days. 

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 Prostaglandins: main types and functions  This procedure involves injecting a 0.2 ml microbolus just above the periosteum and a 0.1 ml microbolus very shallow, just below the epidermis. At each session, 3 ml (1 ampoule) of the drug was injected (1.5 ml on each side of the face). 

All assessments were performed unilaterally at the following time points: 

initial state (T0);

• T3 + 1d – one day after the last session of Sunekos® injections; 200;
• T2M – two months after the first injection session;
• T3M – three months after the first injection session. 
The study included five visits: baseline, two intermediate visits, and two follow-up visits. 

Composition of the drug
•  

SUNEKOS® 200

– class III medical device, which is a vial with sterile lyophilized amino acids: glycine, L-proline, L-leucine, L-lysine, L-valine, L-alanine, as well as sterile ampoules with low molecular weight hyaluronic acid. Manufacturer -  

Professional Dietetics SpA

The drug is used for skin bioregeneration, combating photoaging and age-related changes. This formula has received an international patent, as it promotes the simultaneous production of both collagen and elastin. The exclusive distributor of the drug in Ukraine – DMK Ukraine. 

Clinical Assessments
•  
Clinical evaluation was performed as follows: 

1. The area around the eyes ("crow's feet") 

assessed on a clinical scale:  After visual inspection, "crow's feet" were evaluated

on an internal photographic scale

(from 0 – no wrinkles to 7 – very noticeable wrinkles). Dark circles and bags under the eyes were rated on a visual scale from 0 (none) to 4 (very noticeable). 

2. Non-invasive instrumental evaluation:

 

Wrinkle profilometry

(compact portable device Primos, GFMesstechnik, Germany). Assessment of the skin color of the eye area using optical colorimetry (Chroma Meter CR-200®). 

Test group
The study was conducted on 22 female volunteers aged 44 to 65 years (mean age 53 years) with dark circles and bags under the eyes. Each signed an informed consent to participate. 

Results
The percentage change from T0 obtained at each clinical evaluation is shown in Figure 1 below. 5-7. Only four patients in the study group suffered from bags under the eyes. Although no statistical data were obtained to properly assess the reduction in the volume of bags, experts noted a significant improvement in the condition (Fig. 3). 

The results obtained showed a significant reduction in crow's feet; on a visual scale (at least 1 point), respectively, in 48% of patients with a condition on T3i + 1d, in 71% – on T2M and 76% – on T3M. Starting with T2M, there was a significant reduction in dark circles (at least 1 point on the visual scale) – in 52% of patients with a condition on T2M and in 71% - on T3M (Fig. 4).

Fig.3

Instrumental scores

1. Skin profilometry

Analysis of photographs of the area around the eyes ("crow's feet") confirmed the results of clinical assessments (Fig. 5). Also, there was a decrease in Ra (average roughness of the analyzed profile) by 15.4% in T3i + 1d, by 24.6% in T2M and by 26.8% in T3M (Fig. 6). 

2. Skin Color Assessment

Optical colorimetry showed a statistically significant improvement in the L* parameter, which indirectly affects skin radiance, starting at T3i + 1e (according to the Wilcoxon signed rank test with Holm-Sidak correction, p <0.05, T3i + 1e, T2M and T3M compared to T0); in particular, the skin became more radiant by 4.2% in T3i + 1d, by 7.7% in T2M and by 7.8% in T3M (Fig. 7). 

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 Intestinal Health – pledge of beauty and youth  Furthermore, there was a clinically/statistically significant increase in the a* parameter (skin redness), namely 16.4% in T2M (according to the Wilcoxon signed rank test with Holm-Sidak correction, p < 0.05, compared with T0) and by 10.9% in T3M, which indicates an improvement in microcirculation in the skin and a decrease in vascular congestion, most likely due to the

bioregenerating effect

 of the study drug. 

Volunteer performance evaluation
At the end of the study (T3M), each patient completed a questionnaire on the effectiveness and tolerability of the procedure. 

Considering all the answers "medium", "noticeable" and "very noticeable" positive feedback from volunteers about the aesthetic effect of the procedure is obvious. 

Portability
Some patients have experienced mild/moderate hematomas at multiple injection sites after one or more treatments, which disappeared within 5 to 15 days; such reactions refer to the expected consequences of the injection procedure, which are not related to the test drug.

The study director assesses the tolerability of the drug as good or excellent in 100% of patients, which is also confirmed by the assessment of the subjects themselves. 

Visual Scale Score (Average)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fig. 5. Intensity of wrinkles around the eyes (according to the crow's feet photo scale)

 

µm (average value)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fig. 6. 

Ra (medium roughness)  

Parameter L* (average value)

 

 

 

 

 

 

 

 

 

 

 

 

 

Fig. 7. 

Parameter L* (skin radiance) 

Conclusions

  Clinical and instrumental results clearly show

significant aesthetic efficacy of SUNEKOS® injectable; 200

for the eye area. Under-eye wrinkles, dark circles and bags look less noticeable. The new method will certainly be of great interest to specialists 

Fig. 1-2, 4-7 

(c) Dr. Adele Sparavigna; fig. 3 (c) Jana Schmitt-Hau 

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