Objectives: We are currently conducting a clinical trial to evaluate the efficacy and tolerability of our automated microneedling device (SkinPen) to improve Fine Lines and Wrinkles on the face and neck.

Introduction: We are conducting a clinical trial to assess the efficacy and tolerability of microneedling with SkinPen on fine lines and wrinkles of the face and neck, in men and women ages 35 through 65 years. The primary clinical outcome will measure whether it produces a statistically significant improvement in fine line and wrinkle appearance over the course of 90 days and improvement in Clinician’s Global Aesthetic Improvement Scale (CGAIS) when compared with baseline scores.

Materials / method: 33 participants with Fitzpatrick Skin types I-VI are enrolled in this 7-visit study. Treatment of fine line and wrinkles of each participant is done with the SkinPen Precision System at dept following modified instructions on the IFU. Treatment of the face and neck is being performed at depths of up to 2.5mm Facial wrinkling and fine lines are assessed using the G. Lemperle Wrinkle Assessment Scale and the Carruthers Scale. Data collection includes imaging procedures, non-invasive procedures, skin biopsies and completion of a GAIS.

Results: Interim analysis and preliminary results will be obtained by 15 Dec 2019. The anticipated last patient visit is 07 Jan 2020. Interim Results will be presented.

Conclusion: The efficacy and tolerability of SkinPen to improve fine lines and wrinkles on the face and neck is yet to be determined as mentioned above.

Disclosures

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

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

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): Work for the Sponsor

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...: Patent Pending
and status : 2017

This work is presented thanks to the support of: Crown Laboratories

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: 1: Analysis of "the Aging Face"
2: Evaluation of different approaches
3: Menage "the Aging Face" with a a novel temperature-controlled percutaneous radiofrequency device
4: Clinical results after the endodermic radiofrequency treatment

Introduction: Excessive skin laxity due to loss of collagen and elastin, prominence of platysmal banding, jowling along the mandibular border, represent prominent indicators of aging. Skin tightening procedures are one of the fastest growing market segments. A novel, minimally invasive, temperature-controlled, percutaneous radio frequency has been used for tightening of lax facial, cervical skin and body skin.

Materials / method: Several patients with broad age where treated with a minimally invasive temperature-controlled subdermal radiofrequency device that uses a percutaneous treatment probe of 7,5 cm. The coated probe is passed directly under the skin in the hypodermal-subcutaneous fat space. The RF energy is emitted from the tip of the cannula, from the active uncoated region of 1 cm. The delivery of thermal energy causes denaturation and contraction of collagen with subsequent de novo regeneration of collagen and tissue remodeling over weeks to months.

Results: The procedure caused an immediate tightening and then a strong deep dermal and subdermal neo-collagenesis with enhanced skin contour and elasticity. The percutaneous radiofrequency also improved superficial skin quality. The procedure was also performed on patients in combination with liposuction, with a similar skin tightening effect. No major side effects or postinflammatory hyperpigmentation were observed. Patient didn’t experience discomfort post operatively, edema and swelling was present only for hours, without any limitation for social engagements .

Conclusion: Temperature- Controlled Percutaneous radiofrequency is safe, minimally invasive, and effective for tightening of the face, neck and body.

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 this presentation we are describing a new paradigm in adipocyte transfer. Since the fat tissue is the most fragile tissue in the body, to get best results you should behave gently. Our new tools called "Adinizer" and new protocol "Gentle Touch System" will be presented and people will learn how adipocytes could be sized as like HA fillers for different anatomical areas and different indications. Also, participants will learn to produce regenerative cells mechanically with alive adipocytes as like simultaneous cell enriched therapy.

Introduction: Until today, many types of fat tissue grafting techniques have been described in the literature such as macrofat, microfat and nanofat. We are describing a new approach with using our patented ultra sharp blade system named, "Adinizer". Adipose tissue is the one of the most fragile tissue in the body and we described "Gentle Touch System" with patented protocol.

Materials / method: 62 patients have been operated with our protocol with Adinizer as Adjustable Regenerative Adipose Tissue (ARAT) technique.Fat grafting has been used in face, breast, buttock, penis, extremities in different indications. Patients were followed minimum 6 months after operations. Analysis has been performed photographically, MRI imaging, ultrasound imaging and doppler if possible. Also patient satisfaction has been also has been evaluated. Cell integrity and viability have been analyzed histopathological.

Results: Adipose tissue has been cut with 4000, 2400, 1200, 600 and 400 microns ultra sharp blade system (Adinizer) and sizing of the adipose tissue obtained as diameter as requested in different anatomical areas and in different indications. Also, regenerative cells has been produced as mechanical with our patented protocol. Cell integrity and viability has been proved by histopathological. More fat tissue retaining and more regenerative effect have been obtained. All patients has been satisfied after this approach

Conclusion: Nanofat grafting is one of the most performed operation in aesthetic plastic surgery. The most important feature of nanofat is regenerative affect due to regenerative cells in adipose tissue. But due to blunt pressure in inter-syringe maneuvers kills the fat tissue and there is no volume effect after nanofat grafting due to unviable adipocytes. We created a new paradigm in adipocytes transfer: We can cut the fat tissue using patented ultra sharp blade system (Adinizer) under minimal pressure in sizes of 4000, 2400, 1200, 600 and 400 microns according to anatomical area and indications.

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: Objectives
Educate on differences between various technologies for neuromuscular stimulation.

Introduction: Introduction
In 2018 a high-intensity magnet technology was introduced that was scientifically proven to induce muscle hypertrophy and fat apoptosis. Such novel use of magnets in aesthetics creates an urgent need to better educate the community about differences between various modalities that are able to affect the muscular tissue andwith this build up muscle and decrease fat by apoptosis

Materials / method: Muscle contraction can be induced with currents of approx. >10mA. TENS uses direct lower-intensity currents to affect sensory nerves for pain signals blocking. EMS uses moderate-intensity direct currents that elicit superficial contractions + blood flow increase (flow in fascia!) Electromagnetics bypasses the skin + focuses energy to muscles. Electromagnetic (EM) devices are intended for physiotherapy indications and thus use smaller-spot focused fields + shorter protocols. HIFEM is the only EM technology specifically developed for aesthetics and it allows the highest-intensity

Results: HIFEM achieve changes in muscles + fat.is positioned in the very-low frequency spectrum which contrary to the high-frequency band (RF) does not create any heat in the application area and is thus risk-free in terms of burns, scarring or swelling. There are significant differences in muscle-affecting technologies that play a role in the safety profile and treated indications. While TENS, EMS and physiotherapy EM technologies are the better tools for blood flow changes, pain management and healing acceleration, HIFEM tops the other technologies in the ability to deliver visual improvement

Conclusion: The devices are "must" have for Centers working in the field of aesthetic fat removal: After liposuctions they can be used to tigthen the gap between rectus abdominis muscles ( eg after giving birth) and for the same reason it is a great tool after non invasive fat removal eg after cryadipozytolisis. coolsculpting works with mechanical stess to the adipozyte and HIFEM adds apoptosis (+91% described!) and muscle strength to the procedure - this results in a flat Abdomen and unique results. However it can be used at arms and legs as well (muscles!)

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 define a study context that allows comparison of body contouring effects of potential body contouring drugs with deoxycholic acid (DA) at a dose regimen that demonstrates lipolytic effect in MRIs and is sufficiently tolerated to allow completion of the study. An additional objective is to demonstrate the advantages of 3-dimensional MRI imaging in conjunction with photo documentation of local post-injection reactions and blinded histopathological evaluation in providing a substantial basis for providing the rationale for further development of DBI-500 as an injectable body contouring drug.

Introduction: Expansion of DA use for body sculpting beyond unwanted submental fat has been hampered by an exaggerated local inflammatory reaction in a subpopulation of clients that cannot be prospectively identified and therefore excluded from treatment.
There were 408,000 body-sculpting procedures performed in 2017. In that year, the most frequent procedures were cryolipolysis (208,00), radiofrequency (89,000), followed by deoxycholic acid (46,000).
A potential alternative injectable agent should demonstrate superior efficacy and/or tolerability compared with DA.

Materials / method: Three minipigs were dosed with 0.5% or 1.0% of DBI-500, 1.0% DA, a combination of 1% DBI-500 + 1.0% DA, or placebo (saline). Each dose was administered 6 or 4 weeks prior to study end. Each dose consisted of 6 injections of 1mL for a total volume of 6 ml and injected 1.3 cm vertically. Injections for each dose group were done into tattooed grids of of 1 by 1 cm and a total area of 3 by 3 cm. These injections were 1 cm and 2 cm apart (sagital versus transverse plane).
Blinded histological slide review was performed by TPL Path Labs, Freiburg, Germany. Clinical assessments were also done.

Results: Review of serial MRIs in conjunction with 3D depictions (RadiANT™ Dicom Reader) of the injection areas clearly demonstrated reduction of subcutaneous fat deposits of both compounds. However, Post-injection photos of the injected areas indicate superior tolerability of DBI-500.
An experienced external histopathologist performed a blinded assessment of signs of inflammation in the respective histological slides. The analysis demonstrated a statistically significant reduction in inflammation scores (P<0.016) at 4 weeks. No significant effects on body weight or clinical labs were observed.

Conclusion: A minipig model utilizing MRIs and adequate density and depth of injections into dorsal subcutaneous fat is an efficient means of comparing potential injectable body contouring agents with that of the currently FDA-approved drug (deoxycholic acid).
Using this methodology, we were able to demonstrate at least comparable efficacy with superior tolerability of DBI-500 compared with DA at 5-fold greater volume per injection than recommended in the prescribing information of DA.
These results warrant further development of DBI-500 for body sculpting and cellulite.

Disclosures

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

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): Co-founder of company

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...: Approved
and status : EU patent 2019

This work is presented thanks to the support of: Dale Biotech, LLC.

Objectives: Understanding Renuvion in treatment.

Introduction: A retrospective chart review of 13 patients at two clinical sites was conducted on patients who have previously undergone a neck procedure where a helium driven plasma radiofrequency device was used for subdermal coagulation. The purpose of this study was to collect safety and procedural information and perform method validation for effect of tissue coagulation.

Materials / method: This study was a retrospective chart review in which the paper medical records or EMR system were reviewed for patients meeting the eligibility requirements. Procedural and safety information was collected along with images of the treatment areas and compared to pre-procedure photos. This comparison was used for method validation of the effect of tissue coagulation in the neck and submental region. In order to be eligible for analysis, the photos must have met the review eligibility criteria for photo consistency, as established by the independent review committee. All photos meeting this

Results: A total of thirteen (13) patient charts were reviewed. Method validation for the effect of tissue coagulation was demonstrated in the submental region by an average 82% correct identification of the post-image by the blinded reviewers. The mean patient follow-up was 4 months (range: 1 day – 7 months) post-procedure. All of the patients were female (n=13/13), aged 42 to 76 years of age, with an average BMI of 22 (Range 19-26). In 100% of patients, a 1:1 infiltrate mixture was utilized. Ultrasound-assisted method, with power, was used to perform undermining in 9 of the subjects and cannula

Conclusion: A retrospective review of 13 patients, who underwent a neck procedure where a helium driven plasma radiofrequency device was used as a tool for subdermal coagulation, was conducted. Device safety was demonstrated in these patient treatments by the lack of serious adverse events or unexpected events. Method validation for the effect of tissue coagulation was demonstrated by the correctly identified percent of images in the blinded review.

Disclosures

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

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

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: Apyx Medical