Mechanical Coring for Skin Tightening

Recruiting at 1 trial location

Overseen By David Berman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Infection, Cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new method called mechanical coring to determine its safety and effectiveness in tightening skin in specific areas, such as under the arms or behind the ears. The study will evaluate whether this technique can achieve skin tightening without surgery. It is open to healthy men and women aged 30 to 70 who have not undergone certain skin treatments in the past six months. Individuals with a history of skin issues like keloid scarring or those who smoke may not qualify for this trial. As an unphased trial, it offers a unique opportunity to explore innovative, non-surgical skin-tightening techniques.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (medications that prevent blood clotting), you may need to stop them due to the risk of excessive bleeding.

What prior data suggests that mechanical coring is safe for skin tightening?

Research has shown that mechanical coring, a method for skin tightening, is generally safe. A study on micro-coring technology found it effectively reduces facial wrinkles, indicating that the procedure is well-tolerated. It works by removing tiny pieces of skin, which boosts collagen (a protein that supports skin) and improves skin texture.

In previous studies, patients experienced minimal side effects, such as temporary redness and mild swelling, similar to other skin treatments. No serious side effects have been reported. While researchers continue to study this procedure, these findings offer some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional skin tightening treatments that often rely on lasers, radiofrequency, or ultrasound to stimulate collagen production, the micro-coring treatment offers a unique approach by mechanically removing tiny cores of skin. This method is thought to prompt the skin to naturally tighten and rejuvenate itself without the need for heat or chemical interventions. Researchers are excited about this technique because it has the potential to achieve significant skin tightening results with minimal downtime and reduced risk of scarring compared to conventional methods.

What evidence suggests that mechanical coring is effective for skin tightening?

Research has shown that a method called mechanical coring for skin tightening holds promise in reducing wrinkles and tightening skin. In this trial, participants will receive Micro-Coring treatment, which tightens skin by removing tiny pieces of skin, helping the remaining skin to tighten and smooth out. A study examining skin tissues under a microscope demonstrated that this technique can visibly reduce loose skin and wrinkles. Early results from initial studies support its safety and effectiveness in improving skin appearance. This treatment may offer a non-invasive option for those seeking to rejuvenate their skin. ^{1 2 3 4 5}

Who Is on the Research Team?

Matthew Gronski, PhD

Principal Investigator

Venus Concept

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 30-70 who can consent and follow the study plan. Women must use birth control and have a negative pregnancy test. Participants with any skin type are welcome, but those with darker skin (Fitzpatrick V or VI) will be limited to 25% of the group. People with recent aesthetic treatments, infections, poor healing, certain medical conditions, cancer history, allergies to specific drugs, current participation in other trials or smokers cannot join.

Inclusion Criteria

Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline

Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI

Able and willing to comply with the treatment/follow-up schedule and requirements

Exclusion Criteria

Active smoker or having quit smoking in the last 3 months

Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device

I haven't had cosmetic skin treatments under my arms or behind my ears in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mechanical coring treatment for skin tightening at up to 6 treatment areas on the body

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

6 visits (in-person) at 2, 5, 14, 28, 60, and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Directional Skin Tightening

Trial Overview The trial tests a device called VENUS AIME (RoboCor) for directional skin tightening through mechanical coring. It's a forward-looking study conducted across up to three centers involving multiple treatment areas on the skin to assess both safety and effectiveness.

How Is the Trial Designed?

Group I: Micro-coring treatment Experimental Treatment 1 Intervention

Directional Skin Tightening is already approved in United States for the following indications:

Approved in United States as Mechanical Coring for:

• Skin laxity
• Fine lines and wrinkles
• Uneven skin texture

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Published Research Related to This Trial

A total of 136 incident reports related to dermal fillers were analyzed, involving 143 patients, with the most common issue being the formation of nodules in 89 cases.

Most incidents required either conservative or surgical treatment, highlighting the need for careful monitoring and potential corrective actions for dermal filler products under German medical device regulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survey of incidents associated with injectable dermal fillers reported to the German Medical Devices Vigilance System]. Heinz, BC., Ladhoff, U., Kahl, Ch., et al.[2016]

Radiofrequency (RF) technology is highlighted as a leading method for non-invasive and minimally invasive skin tightening, showing promising results in clinical applications.

The article also addresses the financial considerations and successful business models for implementing RF skin-tightening technologies in plastic surgery practices, emphasizing their value beyond just clinical efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radio frequency energy for non-invasive and minimally invasive skin tightening. Mulholland, RS.[2022]

High-energy pulsed carbon dioxide (CO2) laser resurfacing is highly effective for improving photodamaged or scarred skin, showing better clinical and histological results compared to traditional treatments like dermabrasion and chemical peels.

The treatment also appears to have a tissue-tightening effect, which may contribute to its superior outcomes, suggesting a need for further research into this mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histology of high-energy pulsed CO2 laser resurfacing. Alster, TS., Kauvar, AN., Geronemus, RG.[2019]

ThermiTight, a thermistor-controlled device for skin tightening, showed significant improvement in skin laxity scores, averaging an increase of 0.85 on a five-point scale one year after treatment, indicating its efficacy for nonsurgical facial rejuvenation.

The procedure was generally safe, with only one patient (20%) experiencing a wound complication and another reporting temporary pain, suggesting that while complications are rare, they can occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermistor-controlled subdermal skin tightening for the aging face: Clinical outcomes and efficacy. Sanan, A., Hjelm, N., Tassone, P., et al.[2022]

The demand for nonsurgical facial rejuvenation treatments, like dermal fillers, has increased significantly in the past 20 years, leading to a higher risk of complications and adverse events.

The Assessment Cosmetic Injection Safety Tool (ACIST) has been developed and piloted to standardize pre-injection safety assessments, aiming to reduce adverse events and improve patient satisfaction in cosmetic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a Standardized Facial Cosmetic Preinjection Safety Tool: The ACIST. Elmassian, GM., Owens, SJ., Wood, HJ., et al.[2020]

Aesthetic laser surgery carries risks, and it is crucial for surgeons to understand potential adverse effects to minimize complications during procedures.

Patients should receive thorough education about the risks and expectations of laser surgery to ensure they can recognize and address any complications that may arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of aesthetic laser surgery. Aghassi, D., Carpo, B., Eng, K., et al.[2019]

Micro-coring technology (MCT) is a safe and effective treatment for moderate to severe facial wrinkles, showing a significant average improvement of 1.3 grades on the Lemperle Wrinkle Severity Scale among 51 participants.

The treatment resulted in high patient satisfaction (85.6% reported satisfaction) and a quick recovery time, with an average downtime of only 3 days, making it a promising minimally invasive option for wrinkle reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles. Gfrerer, L., Kilmer, SL., Waibel, JS., et al.[2022]

The UltraPulse CO2 laser treatment resulted in significant skin tightening (43% intraoperatively, 34% at 6 months) due to heat-induced collagen contraction, which appears to provide long-lasting effects without scarring.

In contrast, the erbium laser treatment showed delayed wound contracture effects (42% tightening at 1 month, 36% at 6 months) but was associated with a higher risk of scarring, particularly in patients who received more aggressive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagen tightening induced by carbon dioxide laser versus erbium: YAG laser. Fitzpatrick, RE., Rostan, EF., Marchell, N.[2013]

Cog threads demonstrated significantly greater maximum holding strength (MHS) compared to monofilament and multifilament threads in both cadaver and rat models, indicating their superior ability to tighten skin and soft tissue.

The presence of more myofibroblasts around cog threads suggests they may promote better tissue contracture and healing over time, which could enhance their effectiveness in clinical applications for skin tightening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cog threads under rat skin. Jang, HJ., Lee, WS., Hwang, K., et al.[2022]

Skin tightening treatments, such as radiofrequency, ultrasound, and light-based devices, effectively address skin laxity by heating the dermis to induce collagen contraction and remodeling.

These devices work by targeting the dermis to create new collagen, which helps improve skin elasticity and reduce the appearance of sagging and deep skin folds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin tightening. Woolery-Lloyd, H., Kammer, JN.[2019]

The demand for nonsurgical facial rejuvenation treatments, like dermal fillers, has increased significantly in the past 20 years, leading to a higher risk of complications and adverse events.

The Assessment Cosmetic Injection Safety Tool (ACIST) has been developed and piloted to standardize pre-injection safety assessments, aiming to reduce adverse events and improve patient satisfaction in cosmetic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a Standardized Facial Cosmetic Preinjection Safety Tool: The ACIST. Elmassian, GM., Owens, SJ., Wood, HJ., et al.[2021]

The broadband infrared light device (BILD) for skin tightening showed promising results, with over 90% of treated patients experiencing visible improvement after two treatments, according to a study involving 42 patients.

No complications were reported during the treatments, and patient satisfaction was high, indicating that BILD is a safe and effective option for facial skin tightening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter clinical perspectives on a broadband infrared light device for skin tightening. Taub, AF., Battle, EF., Nikolaidis, G.[2019]

Energy-based devices can effectively tighten skin without the need for surgery by inducing collagen shrinkage and stimulating the body's natural wound healing response to produce new collagen and elastin.

The mechanisms behind skin tightening have been supported by various scientific analyses, including histological and electron microscope studies, confirming the efficacy of these minimally invasive technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin tightening-does it really exist? Boen, M., Vanaman Wilson, MJ., Fabi, S.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04910945

Mechanical Coring to Achieve Directional Skin Tightening See Delay Results Type in the Results Data Element definitions for more information. ... mechanical coring with directional closure to achieve directional skin ...

2. withpower.com withpower.com/trial/mechanical-coring-for-skin-tightening-d4a95

Mechanical Coring for Skin Tightening The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening.

3. trialx.com trialx.com/clinical-trials/listings/237229/mechanical-coring-to-achieve-directional-skin-tightening/?&radius=50

Mechanical Coring to Achieve Directional Skin Tightening This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12216801/

Histologic Study of Abdominal Skin Treated With Mechanical ... Mechanical Dermal Micro‐Coring Technology (MCT; Ellacor System) achieves skin tightening and wrinkle reduction through direct mechanical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03228641

Evaluation of Safety and Efficacy of Micro-coring Device for ... A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring ...