Fractional Radiofrequency for Reduction of Surgical Scar Formation

Launched by VENUS CONCEPT · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called fractional radiofrequency to see if it can help reduce the formation of scars after surgery. The study is currently looking for healthy women aged 21 to 75 who are interested in preventing surgical scars. To participate, you'll need to be able to understand and sign a consent form, follow the treatment schedule, and avoid direct sunlight on the treatment area during the study. If you're of childbearing age, you'll need to use a reliable birth control method and have a negative pregnancy test before starting.

Participants in the trial can expect to receive fractional radiofrequency treatment, which is a non-invasive procedure aimed at improving the appearance of scars. It's important to note that certain health conditions or past medical history, like having metal implants or skin disorders, may prevent someone from joining the study. If you qualify and decide to participate, you'll be part of a process that could help improve how surgical scars heal.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
• • 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. Willing to avoid direct sunlight to the treatment area for the duration of the study.
• • 5. Women of child-bearing 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.
• Exclusion Criteria:
• • 1. Subjects with any implantable metal device in the treatment area
• • 2. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• • 3. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• • 4. Current or history of any kind of cancer, or dysplastic nevi.
• • 5. Severe concurrent conditions, such as cardiac disorders.
• • 6. Pregnancy or intending to become pregnant during the study and nursing.
• • 7. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
• • 8. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
• • 9. Poorly controlled endocrine disorders, such as diabetes.
• • 10. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• • 11. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• • 12. History of bleeding coagulopathies, or use of anticoagulants.
• • 13. Use of isotretinoin (Accutane®) within six months prior to treatment or at physician discretion.
• • 14. Treating over tattoo or permanent makeup.
• • 15. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.