Recruiting

Fractional Radiofrequency

Sponsor:

Venus Concept

Code:

NCT05897723

Conditions

Surgical Incision

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Fractional Radiofrequency

Study Details

Brief summary:

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

Conditions

Surgical Incision

Study ID

NCT05897723

Start date

Sep 1, 2023

Status verified date

Mar, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

All enrolled subjects will undergo breast reduction or breast mastectomy in which scar assessment will be made after pre-surgical treatment in a split-body design, involving a single treatment of RF application to one side of the surgical area(s) within 24 hours prior to the procedure. The subject will act as their own control, where one surgical area will be treated, and the other will not be and will act as the control. Tissue samples will be biopsied from RF treated skin, as well as non-treated skin, at follow up visits. The samples will be used for histological evaluation to assess tissue structure and regeneration following surgery.

Interventions

Fractional Radiofrequency

Fractional Radiofrequency (RF) delivering nano-fractional RF energy, causing fractional ablation and coagulation at the treatment site.

Primary outcome measure

  • Independent blinded assessment [ Time Frame: 6-months after treatment ]
  • Principle Investigator (PI) evaluation of the scar(s) [ Time Frame: 3- and 6-months after treatment ]

Central Contacts and Locations

Central contacts

Locations

UT Southwestern Medical Center, Department of Plastic Surgery

Recruiting

Dallas, Texas, United States, 75390

Contacts

More Information

Sponsor

Venus Concept

Last update posted

Mar 28, 2025

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Venus Concept on 2025-03-28.