Robotic Mechanical Coring for Wrinkles

Recruiting at 1 trial location

Overseen By Gilly Munavalli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Infections, Autoimmune diseases, 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: 6

Duration: Immediate to 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce cheek wrinkles using a robotic device that creates and then closes tiny holes in the skin. Known as Robotic Mechanical Coring, this approach aims to determine the safety and effectiveness of the treatment in reducing wrinkles after two sessions. It suits individuals with noticeable cheek wrinkles who have not undergone certain cosmetic treatments in the past six months. Participants should not have active skin conditions or health issues that affect healing. Those dealing with cheek wrinkles and meeting the criteria may consider joining to help advance skincare treatments. As an unphased trial, this study offers a unique opportunity to contribute to the early development of innovative skincare solutions.

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.

What prior data suggests that this robotic mechanical coring is safe for improving the appearance of wrinkles?

Earlier research on a robotic micro-coring device showed promising safety results. Studies on pigs indicated that the procedure was well-tolerated over 28 days, with no serious side effects observed. Additionally, the Ellacor® System, a similar technology, has FDA approval for removing excess skin without surgery, suggesting a good safety record.

In a small human study, the micro-coring device was tested for treating facial wrinkles. The results indicated that the treatment was generally safe, and patients noticed improvements in their wrinkles. No significant adverse events were reported, indicating that serious complications were rare.

Overall, these findings suggest that robotic micro-coring is likely safe for human use, although every treatment carries some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Robotic Mechanical Coring is unique because it uses a robotic device to precisely target and treat wrinkles by coring out tiny columns of skin tissue. Traditional wrinkle treatments, like creams and injections, focus on surface-level improvements or filling the wrinkles. This method, on the other hand, promotes skin regeneration and collagen production from within, potentially offering more lasting results. Researchers are excited because this innovative approach could lead to smoother, more youthful skin with fewer sessions and possibly a quicker recovery compared to existing options.

What evidence suggests that Robotic Mechanical Coring is effective for improving the appearance of wrinkles?

Research has shown that robotic mechanical coring, the treatment under study in this trial, effectively reduces wrinkles, particularly on the cheeks. Clinical evidence supports its effectiveness for treating mild to moderate sagging and wrinkles on the face, making it a popular choice. The procedure uses small needles to remove tiny pieces of skin, enhancing the skin's appearance. Previous studies noted improvements in moderate and severe wrinkles in the middle and lower parts of the face. This method aims to tighten and smooth the skin, reducing visible wrinkles. ^{1 2 6 7 8}

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 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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Mechanical Coring

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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

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

Robotic Mechanical Coring is already approved in United States for the following indications:

Approved in United States as Ellacor for:

• Moderate to severe facial wrinkles

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05091788

Robotic Mechanical Coring for the Treatment of Moderate ... This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement ...

2. withpower.com withpower.com/trial/phase-10-2021-55f41

Robotic Mechanical Coring for Wrinkles Clinical evidence supports the efficacy of this technology for treating mild to moderate facial skin laxity and wrinkles, establishing it as the gold standard ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9837470/

Safety and efficacy of a novel robotic, fractional micro- ... However, their use can result in side effects that include burns, hyper- or hypopigmentation, erosions, scarring, purpura and vascular necrosis,. In addition, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04910945

Mechanical Coring to Achieve Directional Skin Tightening VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles. What is the ...

5. ellacor.com ellacor.com/microcoring-procedure/

Micro-Coring® Procedure Ellacor uses hollow needles to remove micro-cores of skin, resulting in an improved appearance of moderate and severe wrinkles in the mid and lower face.

6. ellacor.com ellacor.com/

Ellacor® System with Micro-Coring® Technology First and only FDA-cleared procedure to non-surgically remove excess skin · of patients showed improvement in moderate to severe wrinkles · overall patient ...

7. 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 ...

8. researchgate.net researchgate.net/publication/390073113_Core_Innovations_in_Skin_Rejuvenation_A_Systematic_Review_of_Microcoring_Technology

Core Innovations in Skin Rejuvenation: A Systematic ... The purpose of this study was to evaluate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of facial ...