Mechanical coring for skin tightening

Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 30 Years to 70 Years
• Sex: All
• Sponsor: Venus Concept (Industry-sponsored)
• Locations: 3 sites (Los Altos, California and 2 other locations)
• Trial ID: NCT04910945 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 30 to 70 who are looking for skin tightening solutions.

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.

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 performed: While mechanical coring is a novel approach, similar techniques in skin tightening have shown promise in other studies.

Eligibility 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 this trial is running

Los Altos, California and 2 other locations

• 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

Conditions Skin Tightening; Healthy Volunteers; Rhytides; Wrinkles; Loose Skin; Skin Laxity; Mechanical Coring; Robotic Coring