Mechanical coring for skin tightening
Official title: Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening
Run by Venus Concept · NCT04910945 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new skin treatment called mechanical coring to see if it can help tighten skin and reduce wrinkles for healthy volunteers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 70 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Venus Concept Industry-sponsored |
| Locations | 3 sites (Los Altos, California and 2 other locations) |
| Trial ID | NCT04910945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy men and women aged 30 to 70 who are looking for skin tightening solutions.
✕Probably not a fit
Patients with recent aesthetic treatments in the targeted areas or those with a history of keloid formation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study evaluates the safety and efficacy of mechanical coring to achieve directional skin tightening. It involves up to 70 healthy volunteers receiving treatment in multiple areas of the body, including the neck, underarms, cheeks, abdomen, thighs, and forehead. Participants will be monitored at various intervals post-treatment to assess outcomes. The study aims to determine how well this innovative approach can improve skin laxity and reduce wrinkles.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for individuals seeking to improve skin tightness and reduce the appearance of wrinkles.
How similar studies have gone: While mechanical coring is a novel approach, similar techniques in skin tightening have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy, male or female subjects between 30 and 70 years of age. 2. Able to read, understand, and voluntarily provide written Informed Consent. 3. Able and willing to comply with the treatment/follow-up schedule and requirements. 4. 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. 5. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI. Exclusion Criteria: 1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months. 2. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area. 3. History of keloid formation 4. Active smoker or having quit smoking in the last 3 months. 5. Active, chronic, or recurrent infection 6. Compromised immune and/or healing system (e.g. diabetes) 7. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study. 8. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements. 9. Pregnant or breastfeeding 10. Any indication that may cause excessive bleeding, e.g., anticoagulants. 11. Carcinoma, melanoma, or any other cancerous condition in the last 6 months. 12. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA). 13. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device 14. Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.
Where it's running
-
Berman Skin Institute
Los Altos, California, United States Recruiting -
Le's Aesthetics
San Jose, California, United States Recruiting -
DeNova Research
Chicago, Illinois, United States Completed
Study contacts
- Study coordinator: Matthew Gronski, PhD
- Email: mgronski@venusconcept.com
- Phone: 888-907-0115
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using Quantum Probe for Skin Tightening in Liposculpture Patients
This study is testing if a new device called the Quantum probe can help tighten loose skin for adults getting liposculpture.
-
Computer-assisted hair restoration using the ARTAS system
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.