Mec Regenerate® – clinical evaluation

Mec Regenerate® is an intelligent extracellular matrix regeneration system and the first stimulator to be certified in accordance with the stringent MDR regulations. The product has already undergone all required safety and efficacy testing and is currently in the final formal stage of the certification process. It is manufactured by the Italian company 303Pharma, which decided to conduct a broad clinical evaluation of the product involving more than 100 patients before its market launch – in Poland, England and Italy. We are sharing the first results!

In Poland, the clinical evaluation of Mec Regenerate® was conducted under the patronage of – as the principal investigator – Prof. Wioletta Barańska-Rybak, MD, PhD, a renowned specialist in dermatology and venereology and the author of numerous recognised and widely cited scientific publications. In Poland, the product evaluation was also carried out by, among others: Gabriela Bogucka, MD, Krzysztof Cudzik, MD, PhD, Agnieszka Górna, MD, Magdalena Kędzia, MD, Barbara Parda, MD, and Elżbieta Zielińska, MD. The first results and effects obtained after a single treatment (assessed after 60 days) are highly satisfactory and, most importantly, noticeable to the patients themselves. The treatment is well tolerated and easy to perform. Detailed results and observations from the evaluation will also be presented at congresses – Prof. Wioletta Barańska-Rybak, MD, PhD, will share them during this year’s iADE conference in Sopot, while in October the investigators will have the opportunity to present them during the international Agora conference in Milan. Beautyeurope.eu is the exclusive distributor of Mec Regenerate® in Poland, the United Kingdom and Germany.

What is Mec Regenerate®?

Mec Regenerate® is an intelligent extracellular matrix regeneration system that opens a new era in skin bioregeneration. It is an innovative combination of four advanced ingredients that become activated at specific stages after administration, initiating a rebuilding process in the skin that follows its natural biological rhythm. As a result, tissue stimulation takes place gradually and predictably, respecting the skin’s natural repair mechanisms, while the effects develop progressively and last for a long time.

MEC Regenerate® does not cause mechanical irritation of the tissues, and collagen production is not the result of the body’s reaction to a foreign body. The product acts through signal modulation of the extracellular matrix environment (ECM, ExtraCellular Matrix**)**, leading to the reconstruction of lost tissue architecture.

Each of the four components of the product performs a specific function in this process:

· Recombinant Alpha-1 collagen is the most biocompatible with human collagen (99.9%), produced by silkworms (a formula patented by 303Pharma). It transmits a signal to integrin receptors and, through a signalling pathway, initiates the regeneration process. Alpha-1 therefore acts as a biomimetic signal for fibroblasts.

· Pro-Elastin – a complex of amino acids: glycine, proline, valine and alanine provides the “building blocks” necessary for the reconstruction of elastic fibres, ensuring targeted support for elastin production. At the same time, it is “fuel” for fibroblasts, supporting collagen production and preventing deficiencies during periods of increased cellular activity.

· Pharmaceutical-grade polycaprolactone (PCL) dissolved in an aqueous environment helps avoid complications associated with conventional forms of “solid” PCL, such as lumps or granulomas. It is not only a biostimulator, but also a modulator and stabiliser of the regenerative signal. Through slow biodegradation, it maintains an environment conducive to regeneration, ensuring long-term collagen remodelling.

· Carboxymethylcellulose (CMC) creates a biocompatible hydrogel matrix that stabilises the product in the tissue and provides an optimal environment for the active ingredients to act and for their controlled distribution. CMC enables uniform administration of the product into the tissues and, at the initial stage, has a moisturising and filling effect.

Histopathological studies have shown that following application of the product there is:

• remodelling of type I collagen, type III collagen and elastin,
• gradual restructuring of the extracellular matrix,
• increasing fibroblast activity,
• improved skin firmness and elasticity.

Stages of product action:

0–7 days – hydration and improved turgor
The skin becomes tighter, better hydrated and regains a healthy glow.

1–4 weeks – collagen remodelling
Skin texture improves, elasticity increases, and fine lines begin to smooth out.

1–3 months – biostimulation
Tissue volume is restored and skin tension improves in the cheek and jawline areas.

3–24 months – long-term regeneration
Extracellular matrix remodelling progresses, dermal density increases, and the lifting effect is maintained for a long time.

A simple and consistent treatment protocol

The Mec Regenerate® product is ready to use, eliminating adverse effects associated with improper preparation. The syringe-ampoule contains 1.8 ml of product, and the convenient graduation allows for precise distribution of 0.9 ml to each side of the face.

Recommended protocol:

• administration with a 22G, 57 mm cannula (included in the package) into the mid and lower face, using a retrograde fanning technique
• two treatments at an interval of 60 days
• if indicated, a third treatment after 6 months may be performed

How was the evaluation conducted?

At the time this summary was prepared, 57 patients had undergone, in accordance with the protocol specified by the manufacturer, two treatments at an interval of approximately 60 days. Before starting the therapy, photographic documentation was prepared (a frontal photograph, two three-quarter profile photographs and one side profile photograph, five photographs in total), and the questionnaire collected information on:

• assessment of the patient’s skin condition by the treating physician,
• assessment of the skin condition by the patient themselves.

Before the second treatment, the effects and their assessment by the patient themselves were documented 60 days after the first treatment. The study included 54 women and 3 men, and the mean age of the patients was 49.6 years. Permissible weight fluctuations during the course of the therapy were no more than +/- 3 kg, so that an objective assessment of the changes induced by skin stimulation and regeneration was possible. The final effects of the therapy will be assessed 6 months after the second treatment. At that point, a third treatment will also be performed if indicated, in accordance with the protocol.

Patient assessment before therapy:

Based on the investigators’ diagnosis, the evaluation included individuals with skin laxity, loss of elasticity, reduced skin tension, loss of density, and signs of ageing in the lower and mid-face. These are typical indications for biostimulation and extracellular matrix regeneration treatments.

The following aesthetic concerns predominated in the medical assessment:

• reduced skin elasticity (84%)
• nasolabial folds (approx. 85%)
• marionette lines (approx. 80%)
• moderate skin firmness (67%)
• moderate skin hydration (60%)

According to the patients themselves, the following indications predominated:

• Loss of a defined jawline (67%)
• Loose skin (60%)
• Nasolabial folds (53%)
• Marionette lines (48%)
• Irregular skin texture (31%)

Before starting the therapy, 55% of patients considered their appearance acceptable, 22% considered it satisfactory, and the same percentage (22%) considered it unsatisfactory.

Assessment of results after 60 days:

• Degree of improvement:

– 27 patients described the aesthetic improvement as mild,
– 26 patients described it as significant.

• The most frequently reported effects included:

– tighter skin – 42 patients (73.7% of the entire group),
– a slight reduction in skin laxity – 42 patients (73.7%),
– improved skin hydration – 28 patients (49.1%).

No changes were reported in 1 patient.

Assessment of treatment comfort (on a scale of 1–5):

• The mean treatment comfort score was 4.27, with 31 patients (55.4%) giving a score of 5/5 and 12 patients (21.4%) giving a score of 4/5.

Adverse effects:

– no adverse effects were recorded in 54 patients (92.9%),
– mild adverse effects were described in 4 patients.

Patients described the mild effects as transient symptoms associated with the cannula treatment itself, such as skin redness, tenderness or slight swelling.

During the 60 days following the first treatment, no complications or more serious or persistent adverse effects were recorded.

Treatment and results through the investigators’ eyes

We asked each investigator to share one selected patient case from the evaluation conducted at their centre/clinic. The results are presented below.

Professor Wioletta Barańska-Rybak, MD, PhD

Case description:

33-year-old woman – initially good skin quality and hydration, reduced elasticity on physical examination, with visible early fine lines and relatively shallow marionette lines. According to the investigator’s assessment, the appearance of the mid and lower face at the time of enrolment in the study was satisfactory. The patient reported increasingly pronounced nasolabial folds and marionette lines, as well as irregular skin texture and a decline in skin elasticity.

Investigator’s assessment:

60 days after the first injection, the improvement compared with the baseline symptoms can be assessed at 25%, as evidenced by the clinical photographs. The patient noted an improvement in skin hydration and firmness. According to the investigator, the treatment technique is simple and safe, while the density of the product requires slow administration, which has a clearly positive effect on patient comfort and results in no post-treatment recovery period. The final clinical outcome will be possible to assess after completion of the full treatment protocol based on 3 injection procedures.

Gabriela Bogucka, MD

Case description:

54-year-old female patient in menopause who noticed a significant decrease in skin density, fine lines around the eyes and mouth, mid-cheek descent and subtle marionette lines. She also had very dry skin.

Investigator’s assessment:

Based on my own assessment, photographic documentation and the patient’s subjective reports, I observed a visible improvement in skin firmness and quality, particularly in the mid and lower face, a subtle improvement in facial contours, a more even skin surface and improved hydration. Although the treatment was performed in the mid and lower cheek area, we also observed an improvement around the eye area, giving the impression of a “more rested eye”. I assess the improvement at 30% compared with baseline. From the physician’s perspective, the treatment is easy and quick; I used a 22/70 cannula. The patient reported no significant discomfort during the treatment and no adverse effects following either the first or the second treatment.

Agnieszka Górna, MD

Case description:

43-year-old female patient presented with visible signs of facial skin ageing. The baseline assessment showed a moderate loss of skin firmness and elasticity, the presence of static wrinkles in the nasolabial fold area, and uneven skin texture. The patient also reported a subjective feeling of tissue laxity and a poorly defined jawline. The main goals of the therapy were to improve skin quality, increase skin firmness and tightness, and enhance the overall appearance and contour of the face.

Investigator’s opinion:

Two months after the treatment, the patient reported a clear aesthetic improvement. Clinical observation showed increased skin tension and a reduction in the degree of tissue laxity. The skin appeared tighter and more uniform in terms of texture. The results achieved were consistent with the intended therapeutic goals, and the overall improvement compared with baseline was assessed at approximately 75%. The procedure was well tolerated. The patient rated the comfort of the treatment at 4/5 on a five-point scale. Adverse effects were mild and limited to slight swelling that persisted during the first 24 hours after the treatment.

From the practitioner’s perspective, I assess the procedure very positively. The ease of product administration, straightforward treatment protocol and lack of need for a recovery period are particularly noteworthy. An additional advantage was the relatively rapid appearance of the first therapeutic effects, meeting the needs of patients seeking an improvement in skin quality with minimal impact of the procedure on their daily activities.

Barbara Parda-Głomska, MD

Case description:

40-year-old female patient with skin laxity in the lower face and damage caused by excessive sun exposure. She wanted to improve skin tightness and elasticity, as well as enhance the definition of the jawline.

Investigator’s assessment:

Excellent improvement in skin tightness and elasticity was observed as early as during the first treatment, with further enhancement of the effects after the second treatment. I assess the degree of improvement compared with baseline symptoms at 75%. The treatment was very well tolerated by the patient, despite her initial concerns about treatment with a cannula. The syringe is excellent, with a helpful graduation at the halfway point of the volume, and comes with an appropriate 22G cannula. The treatment was short and painless for the patient. The aesthetic improvement of the patient’s entire face was very surprising, extending beyond the area where the biostimulator was administered. In my assessment, as well as according to the patient and her friends, the overall appearance of the face was visibly younger. The patient reports that since undergoing the second treatment, people around her have been convinced that she is much younger than her chronological age.

Elżbieta Anna Zielińska, MD

Case description:

54-year-old female patient with initially reduced skin quality. Before the treatment, the skin was dry and lax, with reduced firmness and elasticity, fine lines, poor hydration and decreased skin tension. The jawline was less defined, with visible signs of tissue descent. Hyperpigmentation and dilated blood vessels were also observed; no signs of skin atrophy were noted.

Investigator’s assessment:

The use of Mec Regenerate® was aimed at improving the qualitative parameters of the skin, primarily its density, elasticity, tension, hydration and structure. 60 days after T0, an improvement in the overall condition of the skin was observed, most notably in terms of elasticity and density. Skin tension, hydration, surface texture, the appearance of fine lines and the contour of the jawline also improved. An increase in volume in the zygomatic area was also observed.

The overall degree of improvement was assessed at approximately 50% compared with baseline. The patient subjectively reported a noticeable improvement in skin quality, which was consistent with the clinical observation. Treatment tolerance and acceptability were assessed as good; no swelling or allergic reactions were observed. From the physician’s perspective, the product was comfortable to work with, and the result was consistent with the concept of gradual, natural skin bioregeneration, without a predominant volumising effect.

Magdalena Kędzia, MD

Case description:

46-year-old female patient. A “challenging” patient with thick, heavy skin prone to gravitational ptosis, pronounced nasolabial folds, marionette lines and a double chin. During the evaluation, the patient lost approximately 3 kg (within the permitted weight fluctuation).

Investigator’s assessment:

I observed at least a 50% improvement in skin quality and tightness, an increase in tissue density and hydration and – despite the treatment being performed in the lower face – a clear “opening” of the eye area. Administration of the product is comfortable for the physician, with good control over the amount administered and predictability of the skin layer. The patient experienced the typical feeling of pressure associated with cannula administration, but without post-treatment swelling or bruising. It can be said that the treatment is “maintenance-free” after administration, which is convenient for the patient and also helps us avoid the issue of adverse effects associated with failure to follow post-treatment recommendations. The patient is very satisfied with the results achieved. As she plans to lose more weight after completing the evaluation, I believe that Mec Regenerate® treatment will help her avoid the side effects of weight loss in the form of sagging, lax and loose skin, providing the tissues with density and a natural lifting effect.

Dr Krzysztof Cudzik, MD, PhD

Case description:

52-year-old woman with early-stage loss of skin elasticity, manifested by persistent expression lines in the lower face, in the area of the nasolabial folds and lower cheek, with moderately pronounced skin laxity in this area. Early-stage nasolabial and marionette folds secondary to skin laxity were also observed, as well as sun-induced hyperpigmentation and individual facial telangiectasias. The patient presented with indications for increasing skin density in the lower face and jawline area in order to reduce skin laxity and the secondary formation of marionette and nasolabial folds. There were no indications for volume augmentation of the mid and lower face. I qualified the patient for a series of at least 2 treatments with the Mec Regenerate® biostimulator to improve skin tightness and reduce expression lines in the lower face.

Investigator’s assessment:

After 1 treatment – 60 days after the Mec Regenerate® injection – a noticeable improvement in skin tightness was observed, with a reduction in the nasolabial and marionette folds and decreased visibility of fine, persistent expression lines in the lower face. I assess the improvement at 50% compared with baseline. The treatment with the Mec Regenerate® biostimulator is very well tolerated by patients, and the procedure is technically not demanding. Based on my own experience and observation of the clinical effects of this product, I can confirm noticeable efficacy and patient satisfaction. I am pleased and satisfied with the results of this procedure, as well as with its safety profile, as a minimally invasive skin biorevitalisation treatment dedicated to the lower face.