Robotic Mechanical Coring for Wrinkles

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Venus Concept

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Infections, Autoimmune diseases, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for cheek wrinkles that uses a device to remove tiny pieces of skin and covers them with special tape to help them heal. It aims to improve skin appearance by making it smoother. Up to 70 people will be treated and monitored over time.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medication that can increase bleeding, like blood thinners.

How is the Robotic Mechanical Coring treatment different from other wrinkle treatments?

Robotic Mechanical Coring is unique because it removes small cores of skin without causing scars, unlike traditional laser treatments that can cause thermal damage. This method uses a hollow needle to safely and effectively tighten skin and reduce wrinkles, offering immediate closure and less recovery time. ^{1 2 3 4 5}

Research Team

Matthew Gronski, PhD

Principal Investigator

Venus Concept

Eligibility Criteria

This trial is for men and women aged 22-75 with moderate to severe cheek wrinkles, rated at least a 3 on the Lemperle Wrinkle Scale. Participants must have Fitzpatrick skin type I to IV, use reliable birth control if applicable, and commit to the study schedule. Smokers, those with recent aesthetic treatments or certain medical conditions are excluded.

Inclusion Criteria

Your skin type is categorized as light to medium.

I am using birth control and have a negative pregnancy test.

I am between 22 and 75 years old.

Exclusion Criteria

I have a bleeding disorder or take medication that increases bleeding risk.

I have non-cancerous skin conditions in the area that needs treatment.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two coring treatments on the cheeks with the robotic coring device

Immediate to 1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

4 visits (in-person) at 7, 37, 60, and 120 days post-treatment

Treatment Details

Interventions

• Robotic Mechanical Coring (Procedure)

Trial Overview The Venus Aime procedure is being tested for its safety and effectiveness in reducing facial wrinkles. This involves mechanical coring of the skin followed by closure of cored areas. Up to 70 subjects will receive two treatments in this prospective study across up to four centers.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

All subjects will receive two coring treatments on the cheeks with the robotic coring device.

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Findings from Research

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]

Microcoring technology (MCT) allows for scarless skin removal using a modified needle, providing a safer alternative to traditional thermal energy methods, as demonstrated in three clinical safety trials.

Patients tolerated MCT well, with rapid healing and limited side effects, and showed promising long-term benefits such as skin tightening and increased skin thickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytrellis: A Novel Microcoring Technology for Scarless Skin Removal: Summary of Three Prospective Clinical Trials. Pozner, JN., Kilmer, SL., Geronemus, RG., et al.[2022]

The AimeTM robotic micro-coring device demonstrated effective skin resurfacing in a study involving four pigs, with treatment resulting in complete healing of some sites within just 7 days.

No significant adverse events were observed, indicating that the micro-coring technology is a safe alternative to traditional laser resurfacing methods, which often cause thermal injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a novel robotic, fractional micro-coring device in a swine model. Ramot, Y., Vazana, U., Cacical, O., et al.[2023]

Both subsurface monopolar radiofrequency (SMRF) and microfocused ultrasound with visualization (MFU-V) effectively reduced neck laxity in a study of 20 subjects, showing significant improvements that persisted for up to 180 days after treatment.

There were no significant differences in efficacy or patient satisfaction between the two treatments, although MFU-V was associated with more procedural pain, indicating that both methods are safe and effective options for neck lifting and tightening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Evaluator-Blinded Trial Comparing Subsurface Monopolar Radiofrequency With Microfocused Ultrasound for Lifting and Tightening of the Neck. Jones, IT., Guiha, I., Goldman, MP., et al.[2018]

The ThermaCool System uses nonablative monopolar capacitive radiofrequency technology to rejuvenate facial skin by heating the underlying dermis while protecting the skin surface, which reduces recovery time and complications.

Clinical evidence supports the efficacy of this technology for treating mild to moderate facial skin laxity and wrinkles, establishing it as the gold standard for noninvasive skin tightening treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monopolar radiofrequency skin tightening. Abraham, MT., Mashkevich, G.[2008]

References

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

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

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

Cytrellis: A Novel Microcoring Technology for Scarless Skin Removal: Summary of Three Prospective Clinical Trials. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a novel robotic, fractional micro-coring device in a swine model. [2023]

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

A Randomized Evaluator-Blinded Trial Comparing Subsurface Monopolar Radiofrequency With Microfocused Ultrasound for Lifting and Tightening of the Neck. [2018]

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

Monopolar radiofrequency skin tightening. [2008]