UnknownNot Applicable

Fractional Radiofrequency for Reduction of Surgical Scar Formation

United States20 participantsStarted 2023-09-01

Plain-language summary

Safety and Efficacy of Fractional Radiofrequency for the Reduction of Surgical Scar Formation

Age range21 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
✓. Able to read, understand and voluntarily provide written Informed Consent.
✓. Able and willing to comply with the treatment/follow-up schedule and requirements.
✓. Willing to avoid direct sunlight to the treatment area for the duration of the study.
✓. 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.

✕. Subjects with any implantable metal device in the treatment area
✕. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
✕. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
✕. Current or history of any kind of cancer, or dysplastic nevi.
✕. Severe concurrent conditions, such as cardiac disorders.
✕. Pregnancy or intending to become pregnant during the study and nursing.
✕. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
✕. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.

Independent blinded assessment

Timeframe: 6-months after treatment

Principle Investigator (PI) evaluation of the scar(s)

Timeframe: 3- and 6-months after treatment

NCT IDNCT05897723

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-31

Andrea Biro, MSc.

Who can participate

Age range21 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy, female subjects 21-75 years of age who are seeking pre-treatment for the prevention of surgical scars.
✓. Able to read, understand and voluntarily provide written Informed Consent.
✓. Able and willing to comply with the treatment/follow-up schedule and requirements.
✓. Willing to avoid direct sunlight to the treatment area for the duration of the study.
✓. 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.

✕. Subjects with any implantable metal device in the treatment area
✕. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
✕. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
✕. Current or history of any kind of cancer, or dysplastic nevi.
✕. Severe concurrent conditions, such as cardiac disorders.
✕. Pregnancy or intending to become pregnant during the study and nursing.
✕. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
✕. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.