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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Mechanical Coring for Skin Tightening?

Research on micro-coring technology shows it can tighten skin and reduce wrinkles without scarring. Additionally, other skin-tightening methods like radiofrequency and infrared light devices have shown visible improvements in skin appearance, suggesting that similar techniques can be effective. ^{1 2 3 4 5}

Is mechanical coring for skin tightening safe for humans?

Research on micro-coring technology, which is similar to mechanical coring, shows it can remove skin without causing scars, suggesting it is generally safe for treating facial wrinkles. ^{4 6 7 8 9}

How is the treatment Mechanical Coring for Skin Tightening different from other skin tightening treatments?

Mechanical Coring for Skin Tightening is unique because it involves removing small cores of skin to tighten the skin without causing scars, unlike other treatments that use heat or energy to induce collagen contraction. ^{4 10 11 12 13}

Research Team

Matthew Gronski, PhD

Principal Investigator

Venus Concept

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Thermistor-controlled subdermal skin tightening for the aging face: Clinical outcomes and efficacy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Multicenter clinical perspectives on a broadband infrared light device for skin tightening. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Histology of high-energy pulsed CO2 laser resurfacing. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of aesthetic laser surgery. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Establishing a Standardized Facial Cosmetic Preinjection Safety Tool: The ACIST. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Establishing a Standardized Facial Cosmetic Preinjection Safety Tool: The ACIST. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Survey of incidents associated with injectable dermal fillers reported to the German Medical Devices Vigilance System]. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Collagen tightening induced by carbon dioxide laser versus erbium: YAG laser. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Skin tightening-does it really exist? [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Effect of cog threads under rat skin. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Skin tightening. [2019]