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Fractional Radiofrequency for Surgical Scars

N/A
Recruiting
Research Sponsored by Venus Concept
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-, 3- and 6-months after treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial found that fractional radiofrequency was safe and effective in reducing surgical scarring.

Who is the study for?
This trial is for healthy women aged 21-75 looking to prevent surgical scars. Participants must avoid sun exposure on the treatment area, use reliable birth control, and not be pregnant or nursing. Exclusions include cancer history, severe conditions like heart disorders, skin issues in the treatment area, certain medications including isotretinoin within six months, metal implants near the treatment site, uncontrolled diabetes, bleeding disorders, pacemakers or similar devices.
What is being tested?
The study tests the safety and effectiveness of Fractional Radiofrequency in reducing scar formation after surgery. It's a preventive pre-treatment aimed at minimizing scarring for those undergoing surgical procedures.
What are the potential side effects?
While specific side effects are not listed here, fractional radiofrequency treatments may typically cause temporary redness, swelling at the treated area or changes in pigmentation. There could also be a risk of burns if not done correctly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-, 3- and 6-months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 3- and 6-months after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Independent blinded assessment
Principle Investigator (PI) evaluation of the scar(s)
Secondary study objectives
Colorimetry
Histological Assessment
Scar Morphology
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,304 Total Patients Enrolled

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT05897723 — N/A
Surgical Incisions Research Study Groups: Treatment Group
Surgical Incisions Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT05897723 — N/A
Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05897723 — N/A
~9 spots leftby Nov 2025