Mechanical Coring to Achieve Directional Skin Tightening

Launched by VENUS CONCEPT · May 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new method called mechanical coring, which aims to tighten the skin in a specific direction. The researchers want to see how safe and effective this technique is for people who want to improve the appearance of their skin. The trial is open to healthy men and women aged between 30 and 70, as long as they can understand and agree to participate in the study. It’s important for participants to be in good health and not have had recent skin treatments in the areas being studied, such as under the arms or behind the ears.

If you join this trial, you will receive the mechanical coring treatment and will need to follow up with the study team as required. Participants should be aware that those who are pregnant, breastfeeding, or have certain health issues, like a compromised immune system or a history of keloid scars (raised scars), may not be eligible. This study is currently looking for volunteers, and it’s an opportunity to contribute to research that could help improve skin tightening treatments in the future.

Gender

ALL

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.