HIRONC

In the March issue of D&PS, Korea's most recognizable aesthetic magazine, our KOL of V-RO LIFTING (export name: new doublo) wrote about the clinical effect of New Doublo.

If you have problem in viewing this article, please check the attached document for original article and translated version.   

V-RO LIFTING (Export Name: New Doublo^TM)​

Synergy Effect of HIFU+RF

Jang Hyoseung MD (Director of Forever Clinic, Incheon Bupyeong branch, Korea)

The link between lifting the mandate to wear masks indoors and the increase in demand for skincare is difficult to explain in theory. However, people who have had skin problems due to wearing masks for a long time might have an experience to seek out skin treatments to solve these problems.

In addition, the desire to improve the appearance of individuals due to society-wide lookism is raising expectations for the increase in demand for skincare treatments, which have been stagnant for a while.

The negative effects of long-term mask wear on the skin can be summarized as follows.

① Acne: Wearing a mask creates a warm and humid environment, which increases sebum production, which can lead to acne. It is so common that the new word "maskne," which means acne rash caused by wearing a mask, has emerged.
② Stimulation and rash: the constant friction and pressure of the mask on the skin causes irritation and rash, especially in areas where the skin is already sensitive, such as around the mouth and nose.

 ③ Dry skin: Wearing a mask reduces the amount of air that reaches the skin, causing moisture loss.

To mitigate these effects, it's important to practice good skin care habits, such as keeping your skin clean, hydrating and protecting, and adjusting your mask appropriately to reduce friction and pressure. However, if skin irritation or other problems arise due to prolonged wearing of masks, it is recommended to see a dermatologist in the end.

Even though the four-year mask mandate has been lifted, it is still said that wearing masks are more comfortable than bare faces, but changes in the lifting of masks are slowly being observed in the field.

CLINICAL EVIDENCE FOR V-RO LIFTING (Export Name: New Doublo^TM)

The combination of HIFU and RF was already an excellent aesthetic procedure that had become a trend even before the COVID-19.

However, in order to receive two different treatments at once, there was a burden such as the inconvenience of spending a long time at the hospital and the high cost of the procedure.

V-RO LIFTING (Export Name: New Doublo^TM) emerged in August 2021, amid the recession of COVID-19 to improve this inconvenience, and its usefulness has been widely publicized within the conference even under difficult circumstances.

New products are often shunned in the market due to a lack of clinical evidence.
However, V-RO LIFTING was securing trust in its effectiveness as clinicians shared their experience of use.

In the midst of the COVID-19, it was proved that combined use of HIFU and RF is superior than HIFU alone in effectiveness through its own human trials.

The synergy effect of HIFU+RF was also demonstrated in thermal imaging camera observation performed by HIRONIC.

As a result of measuring the surface temperature of each skin after performing the procedure with the same energy value in Split face, the thermal response of the area was higher in the case of HIFU+RF. (Image 1)

 
 <Image 1.> Skin surface temperature measured by thermal imaging camera: simultaneous HIFU+RF vs. HIFU only. (Sources: HIRONIC)

<Image 2.> Tissue change before and after HIFU + RF irradiation on the back of the micro pig (x50)>

 A: Before HIFU+RF irradiation (H&E stain)

 B: After HIFU+RF irradiation (H&E stain), The darkened red color due to collagen regeneration

 C: Before HIFU+RF irradiation (MT stain)

 D: After HIFU+RF irradiation (MT stain), The darkened blue color due to elastin activation

In addition, in order to confirm the clinical improvement due to higher thermal response, HIFU + RF was irradiated on micro-pigs, the most similar to human skin, and it was confirmed that both collagen and elastin were activated (Image 2)

Through H&E (Hematoxylin and Eosin) and MT (Masson's Trichrome) staining, the activity of collagen and elastin, which is key indicators related to skin elasticity, could be observed more clearly.

H&E staining, which darkens pink as collagen activity increases, and MT staining, which darkens blue with increased elastin activity, both were deepened where simultaneously irradiated with HIFU and RF (Image 3).

Based on these results, human clinical trials were conducted, and a significant improvement in various indicators related to skin beauty was found compared to HIFU alone.

<Image 3> Collagen and elastin activation proved in pre-clinical trials: HIFU+RF vs HIFU. (Source: Hironic)

Compared to HIFU alone, HIFU+RF combined treatment achieved faster and higher improvement and lasted longer.

The average depth of eye wrinkles decreased by up to 1.6 times and, the treatment effect was maintained for over 8 weeks. In addition, the pores that determine the overall skin tone and impression were also very improved.

<Image 4> Comparison through nasolabial imaging: HIFU+RF vs. HIFU (Source: HIRONIC)

<Table 1> Average depth difference in nasolabial line (Source: Hironic)

<Image 5> Comparison through periorbital area imaging.

<Table 2> Average depth difference in periorbital line (Source: HIRONIC)

The combined HIFU and RF treatment showed excellent pore improvement after the first treatment. Compared to HIFU alone, pore density was increased by up to 9.0 times, the number of pore was decreased by up to 13.3 times, and this treatment effect was maintained for over 8 weeks 

<Image 6> Comparison through pore imaging (Source: HIRONIC)

It was confirmed that the treatment results were overally improved in a total of 14 items, and it was observed that there was a remark difference in number of pore, pore density, and inner skin moisturizing of an average of 1.2 ~ 4.8 times and a maximum of 1.4 ~ 13.3 times.​

<Table 5> Skin improvement rate. HIFU+RF vs. HIFU (Source: HIRONIC)

REASON FOR RECOMMENDATION

Although support from large clinical trials may provide clear reasons, it can be assumed that this improvement is due to the activation of glycosaminoglycans (GAGs) by RF.

There are a total of six GAGs (hyaluronic acid·chondroitin sulfate · dermatan sulfate · heparan sulfate heparan sulfate · heratan sulfate) that exist on external surface of cell membrane or outside of cell and play an important role in forming a fiber structure by bridged bond with collagen and elastic fiber molecules in a certain space.

Since GAGs has the ability to bind to water molecules more than 1,000 times its molecular weight, it can be hypothesized that GAGs could have observed this conclusion because it holds water molecules in the skin, inhibiting the skin's water retention and the degradation of collagen and elastic fiber molecules.

V-RO LIFTING (Export name: New Doublo^TM) has now secured not only word of mouth but also trust through human clinical trials. In addition, as a differentiation strategy that can break through the limitations of energy devices, it is a satisfactory device in many aspects such as effectiveness, safety, and reasonable treatment cost.

Since two procedures can be performed at once, the burden of cost and treatment time have been greatly reduced. In addition, considering that it is equipped with a patented safety sensor so that there is no worry about burns, it is recommended to introduce V-RO LIFTING (Export name: New Doublo^TM) that can lead to improved satisfaction with patients' procedures and increased visit rates.

<Image 7> Synergy effect of HIFU and RF proved through human clinical trials (Source: HIRON 

<Image 8> Structure and type of glycosaminoglycan. Scheme showing some proteoglycans and other GAGs (Glycosaminoglycan Chains) of the extracellular space.

(Source: https://international.neb.com/applications/glycobiology-and-proteomics/recombinant-glycoprotein-expression/glycosaminoglycan-chains-gags.)