Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): mage group

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
Yes
Please specify date...: valid
and status : hybrid exosomes

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: Present the efficacy and clinical results of a novel topical PRPlike product

Introduction: PRPs are rich in growth factors, cytokines and exosomes. Several activities as the promotion of angiogenesis or anagen induction, as well as the reduction of oxidative stress or the follicle miniaturization are attributed to PRPs. Studies have demonstrated that increase the follicular bulge cells, the number of follicles and bring various additional benefits related to hair health. In Androgenic Alopecia they bring many benefits but also possess limitations and variability, since the presence of actives, inhibitors, platelet numbers and the presence of red or white blood cells are variable.

Materials / method: The activity of technologies as peptides that mimics the PRP activity has been demonstrated. The identification of Cyclosporin’s (CSA) mechanism of action, lead us to develop a mimetic molecule that exhibits Cyclosporin’s desirable side effect of hypertrichosis. With the addition of four other biomimetic peptides that mirror the activity of VEGF and FGF and in combination with known antioxidants that promote hair health and reduce oxidative stress we have produced a combinatory PRP-like topical technology that has been tested in various clinical studies

Results: A clinical trial of 100 subjects and the results will be presented; in summary, an anagen increase of more than 16% was achieved after 3 months versus T0 and 18% versus Placebo. The Hair Follicle (HF) Diameter was increased by 31% after 3 months versusT0 & 18% versus Placebo. The Hair Mass Index was also increased to 16% (3 months vs placebo) and the Hair Breakage Index to 42% (3 months vs placebo).

Conclusion: The topical PRP-like technology demonstrated significant results that mirror the PRP activity without multiple injections.

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): giuliani

Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): giuliani

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): giuliani

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: giuliani

Objectives: We aimed assessed the improvement in dermal quality and acne scars after PN-HPT™ versus placebo according to Antera 3D® and the patient responses to PSQ after a comparison of pre- and post-treatment photographs at 1, and 3 months.

Introduction: Managing acne scars is a challenge and therapies are divided into nonsurgical and surgical. Highly Purified Technology Polynucleotides, PN-HPT™ are a compound which contains a mixture of DNA polymers of different lengths. Numerous studies have shown that PN-HPT™ also serves as an energy source, thus influencing cellular growth and cells vitality.

Materials / method: We Included women aged 30–50 years old with grade 3–4 moderate-to-severe atrophic scars according to the Goodman classification; nonsmokers; had not had active acne during the past 5 years; Ten patients (PN-HPT™ group) were treated with 4.0 ml of PN-HPT™, and ten patients (control) were treated with 4.0 ml of normal saline. All medical treatments were performed in a double blinded manner; neither the injection doctor nor the patient knew if the PN-HPT™ or the placebo was being administered.

Results: twenty women fit the inclusion criteria were enrolled in this study. Only patients in PN-HPT™ group improved significantly at 1 and 3 months after treatment compared to baseline.

Conclusion: Our prospective and randomized study showed that PN-HPT™ in monotherapy was safe and effective treatment for atrophic scar acne when compared with placebo. Prospective and randomized studies will be necessary to investigate the clinical effectiveness in a larger cohort of patients and for a longer follow up.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: To evaluate the capabilities of using ultrasound elastography and B-histology in studying skin quality before and after injection of HA-based gel.

Introduction: Ultrasound examination makes it possible to assess the condition of the dermis and the subcutaneous fat tissue (SFT) before and after corrections. At the same time, the method has disadvantages, which everyone is well aware of: ultrasound diagnostics is an operator-dependent method. We can’t characterize tissues in numbers and statistically process the data, compare them in dynamics. Elastographic methods of ultrasound wide our opportunities, allow defining tissues strain in numbers more precisely, assessment of therapy dynamics and the effect on soft tissues.

Materials / method: The study involved 32 patients (average age of 46 years). Condition of the dermis and the SFT was assessed using the same technical characteristics of the ultrasound machine (Gain 45, DR 135) and Ultra high-frequency probe (12.5 – 23 MHz) at four identical points before and after the therapy. Ultrasound diagnostics compared tissue sonograms in B-mode, B-histology (measurement and calculation of the gray gradation distribution of ultrasound echo signals within a closed area), as well as assessed the "hardness" of tissues over time using strain elastography and shear wave elastography.

Results: The elastography data obtained: SWE and SE, B-hystology enable to use these methods for quantity evaluation of face soft tissues (dermis and subcutaneous tissue) conditions and may be used as an excellent tool for researches and routine practice. Subdermal skin-booster injections have a positive influence on the dermis quality, significantly increasing its density and amount of white pixels according to multiparametric ultrasound examination.

Conclusion: The resulting data of the study makes it possible to recommend the widespread use of a multiparametric approach in ultrasound assessment of facial soft tissues in cosmetology.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): LABORATOIRE FIJIE

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: To estimate antisenescent/anti-inflammaging properties of HA-bsed cross-linked filler

Introduction: Hyaluronic acid is the traditional basis for dermal implants used in clinical aesthetics to replenish tissue volume and maintain healthy water exchange in the intercellular matrix of aging skin. There are 3 things to extend effectiveness of injectable HA-based cross-linked implants - to manage mechanical tension in the tissue (cell-matrix mechanical sensing), to manage process of senescent fibroblast development and to control SASP. It can be archived by special design of implant's HA-particles.

Materials / method: Senescent/Inflammaging genotoxic model (UVC, fibroblasts) to control activity of several senescence/inflammaging markers (immunocytochemistry: Ki67, SIRT6, Parkin, p65, KLOTHO, HSP90, P38 MAPK) and ATP production (luciferin-luciferase).

Results: Special design of cross-linking of HA molecules and design of HA-particles lead to significant decrease of senescent cells development and SASP secretion by fibroblasts under genotoxic stress conditions. As well it keeps high ATP level in fibroblasts similar to non-damaged cells.

Conclusion: Mechanism of anti-aging activity of HA-based cross-linked fillers with special design of particles probably based on mechanical features of particles and, as consequence, anti-senescent protection of fibroblasts as well as SASP suppression.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: To Explore a approach to the problems of residual deformity of Cleft lip and/or palate (CL/P) in regard of individual surgical anatomy of each patient. Test the feasibility and reliability of 3D designed and printed individualized PEEK material for correcting the complicated residual maxillary deformities and thus setting the stage for correction of other deformities.

Introduction: Cleft lip and/or palate (CL/P) are common congenital malformations affecting the head and neck and one of the most common birth defects. The global incidence of CL/P is reported to be 1.08‰.China is one of the regions with the highest incidence of CL/P. E.g., a meta-analysis in China (1986–2015) showed that the overall incidence of orofacial clefts was 1.4 per 1000 live births9.During the past decade in particular there has been expanding interest in more effective and stable methods of correction of the adult residual deformity.

Materials / method: The DICOM data of the patient (19ys old female) was obtained by 64-row helical cone-beam CT thin-layer scanning (layer thickness <0.6mm) and reconstructed into 3D point cloud data (standard STL format) .The surface data of the patient's face is obtained by 3D scanning equipment. After fitting the two sets of 3D data, we communicated with the patient about the pathologic features of the nasolabial deformity, and discussed the idea of repairing the deformity and the clinical pathway in the 3D scene.Finally, the patient-approved prosthesis is delivered through 3Dprinting.

Results: After correcting the bony structure of the nasal base with the 3D printed PEEK(through oral membrane incision), a high-density porous polyethylene material was applied to correct the deviation of the nasal septum while shaping the ideal position of the anterior angle of the septum. Nasal revison is performed using an endonasal pproach. After the surgery, the patient's nasal shape was significantly improved, the left-right asymmetry of the midface was corrected, the lip shape was normalized, and the quality of life was significantly improved. The patient was very satisfied with the result.

Conclusion: The application of 3D designing and printing tech in the field of plastic surgery will become more and more extensive, and will eventually provide more accurate guidance and prediction for plastic surgery, resulting in more ideal surgical results and higher patient satisfaction.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: To identify clinicopathologic predictors that can accurately stratify sentinel lymph node biopsy-negative melanoma patients by risk of progression, to improve prognostic accuracy and guide personalised treatment decisions.

Introduction: Recent approval of adjuvant pembrolizumab for resected stage IIB/IIC melanoma necessitates tools to precisely stratify high versus low risk patients, to guide treatment decisions and prevent inappropriate immunotherapy toxicity. Using multivariable analyses, this study demonstrates that tumor-infiltrating lymphocyte scoring effectively distinguishes high and low risk subgroups, offering a cost-effective method of guiding personalised treatment decisions.

Materials / method: Multicenter, retrospective cohort study of 1229 cutaneous melanoma patients treated at 2 UK hospitals between 2004-2017, who underwent SLNB. TIL score, Breslow thickness, ulceration, SLNB status, and other clinicopathological factors were examined as potential predictors using Kaplan-Meier curves, univariate analyses, multivariable logistic regression and Cox proportional hazards modeling. Progression was defined as recurrence at local, intransit, regional or distant sites. Regression model fit was assessed by -2 log likelihood, overall chi-square statistics and Hosmer-Lemeshow goodness of fit

Results: The median follow-up duration was 9.5 years, during which the melanoma progression rate after SLNB was 20%. In SLNB-negative patients, TIL score and Breslow thickness were the strongest independent predictors of progression in multivariate analyses. Non-brisk TILs were associated with three-fold higher progression risk and lower progression-free survival compared to absent (p=0.003) or brisk TILs, particularly in stage II patients. Non-brisk TILs and Breslow thickness >2mm identified a high-risk subgroup. In these patients, progression-free survival was 20% lower in males than females (p<0.001

Conclusion: Breslow and TIL scores interact to reliably predict PFS in SLNB-negative melanoma and discriminate between high and low-risk stage II patients. Incorporating SLNB and TIL statuses in prognostic tools holds promise for identifying high-risk patients who may benefit from adjuvant immunotherapy and low-risk patients who may safely forego it.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: - In vitro evaluation of the active ingredients of the studied product in wound healing process
- In vivo investigations of the protective and breathing effects of the product texture
- In vivo analysis of the impact of the product on skin microbiome
- Clinical comparative study in post-peeling to evaluate the tolerance and efficacy of the product in wound healing

Introduction: Applying an adapted moisturizer during the healing process after aesthetic procedures is commonly practiced to help wound healing, to reduce discomfort sensations, and most importantly, the final issue, to lead to absence of pigmented scar. In this context, an in vitro study, four experimental studies and a clinical study were carried out to evaluate the healing effect of a new dermocosmetic product according to the ecobiological approach which considers the skin as a living ecosystem in interface with its internal and external environment, and whose natural biology must be protected.

Materials / method: The active ingredients efficacy was evaluated on injured reconstructed human skin. The protective skin barrier function and breathing effect of the product was investigated via TEWL studies and by measuring the transcutaneous O2 and CO2 partial pressures (radiometer). Then skin microbiome was analyzed via 16S rRNA gene sequencing after disinfection. Finally, the tolerance and efficacy of the product (half-face 2x/14 days) were evaluated after peeling (glycolic acid 70%) in a comparative clinical study (overall scar score of 3 sub-scores: inflammation, scar appearance, soothing effect).

Results: In vitro, the active ingredients improved re-epithelialization, speed of wound closure (D7 91% vs 48% for untreated) and healing quality. A significant improvement of the TEWL was observed after application of blotting paper (20.9%) and after rubbing (11.7%), without variation in transcutaneous O2 and CO2 pressures. The microbiome analysis showed a diversity restoration from 3hrs after disinfection, contrary to the control. Finally, a significant reduction of the overall scar score vs placebo was observed at D3 vs D0 (-56% vs -32%) and D7 (-81% vs -55%) after peeling, with no adverse event.

Conclusion: In conclusion, this new skin healing product designed using an ecobiological approach demonstrates significant activity on natural healing processes while respecting the skin ecosystem (including the microbiome) without pigmentation induction.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: NAOS

Objectives: The objectives of this study were to investigate safety, local tolerability, and efficacy of high intensity focused ultrasound (HIFU) for cutaneous neurofibroma (cNF). cNFs are benign intradermal tumors that can appear in numbers up to several hundred on the skin of neurofibromatosis (NF1) patients

Introduction: High intensity focused ultrasound (HIFU) is capable of controlled and targeted thermo-mechanical treatment to intradermal volumes, without inflicting damage to the surrounding tissue and leaving skin surface without scarring. This treatment modality may be useful for benign and premalignant skin lesions.

Materials / method: Twenty cNF patients were recruited in Copenhagen and Gothenburg centers. Focused ultrasound treatment utilizing a 20 MHz HIFU-device with integrated dermoscopic guidance was performed using a handpiece with a focus depth of 2.3 mm below the skin surface. Single dose acoustic energy of 0.7 J/dose of pulse duration 250 ms/dose was manually positioned until the full cNF was covered. No anesthetic was applied. Primary endpoint was evaluation of safety and tolerance of the HIFU-treatment. Clinical efficacy was reported at 9 months follow-up.

Results: A total of 147 cNFs ( diameter 2-9 mm) were treated. Mild wheal-and-flare reaction was observed immediately after treatment. Occasionally, erosions/crusts were observed and rarely dyspigmentation after 1 week and 3, 6 and 9 months post-treatment respectively. No serious adverse events occurred, and no significant scarring was observed. Visual rating of treated cNFs by the clinical investigator at 9 months showed that 45 out of 92 cNFs (49%) had full or substantial reduction. During treatment the patient-reported pain-score was median 3.5 (range 1-7) on a10 point scale

Conclusion: HIFU treatment is a new non-invasive, rapid, and tolerable treatment modality. This study demonstrates the safety, local tolerability, efficacy, and feasibility of HIFU for the treatment of cNFs. Further studies may open for this new treatment modality to remove other benign, premalignant or even malignant skin lesions.

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): NTAP , Study device from Toosnix

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: Introduce and elucidate a new technology behind new solid biostimulators, offering a combined effects of bio stimulation and lifting and pre-clinical and clinical confirmation of these synergic effects.

Introduction: The quest for effective and sustainable skincare solutions has led to the development of novel solid biostimulators that uniquely combine the benefits of lifting and biostimulation. This presentation delves into the new technology, focusing on the synergistic effects achieved through the integration of lifting and biostimulation mechanisms.

Materials / method: Pre-clinical in-vitro and in-vivo studies showing the results of new technology: threads unique features, pre-clinical of 6 months in-vivo implementation study and clinical study data confirming safety and effectiveness of new technology threads.

Results: Pre-clinical in-vivo implantation results evaluation and clinical application data analysis showed significant long-term improvement of skin quality, reduced recovery period after the procedure and enhanced lifting effect.

Conclusion: New technology of suspension threads is making them as a first solid biostmulator having synergic effect of biostimulation and lifting through mechncical suspension of soft tissues of face and body. The procedure with using the safe, effective product with combination of enhanced long-lasting lifting and biostimulation effect brings it as cost efficient procedure.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability

Objectives: • Primary Objectives
Assess the proportion of subjects who lose at least 150 mL of subcutaneous fat volume as measured by ultrasound compared with placebo
• Secondary Objectives
1. Assess the proportion of subjects who lose at least 200 mL of subcutaneous fat volume as measured by ultrasound compared with placebo
2. Assess the efficacy of up to 4 courses of CBL-514 in reducing subcutaneous fat volume over the treated area as measured by ultrasound compared with placebo

Introduction: The current fat reduction procedures include invasive surgery and non-invasive products. A study has shown that liposuction can remove 183.3mL of abdomen fat on average, yet it may carry the risk of unfavorable outcomes. The efficacy of non-invasive procedures is generally less optimal efficacy with potential side effects.
CBL-514 is a lipolysis injection that can induce adipocyte apoptosis to reduce subcutaneous fat in non-clinical studies. A Phase 2a study showed that CBL-514 significantly reduced 24.96%(p< 0.00001) of fat volume and 7.39mm(p<0.0001) of fat thickness compared with baseline.

Materials / method: CBL-514 was administered via injection into the subcutaneous adipose layer on the abdomen. A total of 76 subjects were randomized in a ratio of 2:1 to receive CBL-514 or placebo. Each subject received up to 4 treatments and up to 600 mg per treatment allocated CBL-514 or placebo administered subcutaneously to the abdomen with a treatment interval of once every 4 weeks, followed by two follow-up visits scheduled at 4 weeks and 8 weeks post the last treatment.

Results: 85.7% and 76.2% of participants lost at least 150mL and 200mL of abdominal subcutaneous fat in the treated area after receiving CBL-514 treatment(s). Compared with placebo, a mean of 312.1mL of subcutaneous fat reduction was observed in CBL-514 group at the 4-week follow-up visit. 42.9% of participants lost at least 150 mL of subcutaneous fat in the treated area after one CBL-514 treatment. Overall, the study demonstrated clinically and statistically significant efficacy of CBL-514 in reducing subcutaneous fat in the treated areas, with favorable safety and tolerability profiles.

Conclusion: The efficacy that CBL-514 performs is similar to or better than liposuction and is superior to existing non-invasive procedures for fat reduction. CBL-514 could be a new, promising, non-invasive treatment for fat reduction.

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): Dr. Gold is an Investigator and performs clinical research for Caliway.

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Caliway

Objectives: Our objective is to provide a step by step guide of how polynucleotide and dermal filler treatments can be safely and effectively combined in order to deliver regenerative results that far surpass what each treatment can do individually.

A live demonstration will show key anatomical landmarks, injection protocols involving both a cannula and a needle as well as safety considerations.

Our objectuve is that this will provide a protocol that practitioners can adapt to each one of their own patients in order to deliver both effective and individualised results.

Introduction: Polynucleotides are an emerging trend within cosmetic medicine, we propose their role in enhancing skin dermis quality and texture when combined with hyaluronic acid injectables for volume correction delivers a far more superior result leading to increased patient satisfaction as well as enhanced results on the landmark wrinkle severity scale scoring.

Materials / method: A step by step protocol has been developed covering how polynucleotides can be effectively injected using a combination of both a cannula and needle technique. We next combined this with a signature 6 point non surgical facelift protocol using hyaluronic acid. 30% of the patients selected had never had any treatment in the past and 70% had undergone a dermal filler treatment at least once.

Results: Patients were consented and treated using a combination of polynucleotide and hyaluronic acid with a follow up protocol to assess treatment efficacy, patient satisfaction and an unbiased rating via the wrinkle severity scale score. There was a 100% patient satisfaction rate with skin texture and quality at the 4 week mark showing significant improvement compared to a dermal filler treatment alone.

Conclusion: By using polynucleotides to treat the skin dermis and simultaneously using hyaluronic acid based dermal filler to restore fat pad depletion and bone resorption associated with ageing, our trial demonstrated superior results and increased patient satisfaction.

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work was not supported by any direct or non direct funding. It is under the author's own responsability