Fractional Radiofrequency for Surgical Scars

Overseen By Matthew Gronski, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Immunosuppressants, Anticoagulants, Isotretinoin, others

Disqualifiers: Cancer, Cardiac disorders, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using isotretinoin (Accutane®), you must stop at least six months before treatment. Also, if you are on immunosuppressive medications or anticoagulants, you may not be eligible to participate.

What data supports the effectiveness of the treatment Fractional Radiofrequency for surgical scars?

Research shows that radiofrequency ablation, a similar technology, is effective in reducing the volume and appearance of keloid and hypertrophic scars, suggesting potential benefits for surgical scars as well. ^{1 2 3 4 5}

Is fractional radiofrequency safe for treating scars?

Fractional radiofrequency has been studied for its safety in treating acne scars and hypertrophic scars (thick, raised scars), showing it to be a generally safe treatment with minimal downtime. ^{3 6 7 8 9}

How does fractional radiofrequency treatment differ from other treatments for surgical scars?

Fractional radiofrequency treatment is unique because it uses a method called fractional photothermolysis, which targets small areas of the skin to promote healing and improve the appearance of surgical scars. This approach is different from traditional fully ablative laser treatments, which remove entire layers of skin, as it allows for faster recovery and less risk of side effects. ^{1 4 6 10 11}

Eligibility Criteria

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.

Inclusion Criteria

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

Able to read, understand and voluntarily provide written Informed Consent

Able and willing to comply with the treatment/follow-up schedule and requirements

Exclusion Criteria

Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant)

I have a permanent implant like metal plates or screws in the treated area.

Subjects with any implantable metal device in the treatment area

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Treatment

A single treatment of radiofrequency (RF) is applied to one side of the surgical area(s) within 24 hours prior to the procedure

1 day

1 visit (in-person)

Surgery

Participants undergo breast reduction or breast mastectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for scar assessment and tissue regeneration through biopsies and various evaluations

6 months

Multiple visits at 1, 3, and 6 months post-treatment

Treatment Details

Interventions

• Fractional Radiofrequency

Trial Overview 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.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+

Findings from Research

A survey of 64 burn patients treated with the Erbium-Yag laser showed that 94% reported some degree of improvement in their scars, with an average satisfaction score of 8.3 out of 10.

The treatment significantly reduced symptoms associated with scars, such as pain and itching, indicating that fractional laser therapy is an effective option for improving burn scar characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser. Madni, TD., Nakonezny, PA., Imran, JB., et al.[2022]

In a study involving 20 patients with post-surgical scars, fractionated Er:YAG laser resurfacing showed a statistically significant superior outcome compared to fully ablative Er:YAG, with physician assessments indicating a 32.5% improvement and patient assessments showing a 58.1% improvement in scar appearance.

Patients preferred the fractionated Er:YAG laser treatment (94% preference) and reported no significant difference in pain levels between the two laser types, suggesting that fractionated lasers may offer better results with similar comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated Er:YAG laser versus fully ablative Er:YAG laser for scar revision: Results of a split scar, double blinded, prospective trial. Tidwell, WJ., Owen, CE., Kulp-Shorten, C., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Fractional photothermolysis for the treatment of surgical scars: a case report. [2006]

2. Ukraine pubmed.ncbi.nlm.nih.gov

THE USAGE OF RADIOFREQUENCY ABLATION FOR TREATMENT OF KELOIDS AND HYPERTROPHIC SCARS. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Reduction of post-surgical scarring with the use of ablative fractional CO2 lasers: A pilot study using a porcine model. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Patient satisfaction after fractional ablation of burn scar with 2940nm wavelength Erbium-Yag laser. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Antera 3D camera: A novel method for evaluating the therapeutic efficacy of fractional CO2 laser for surgical incision scars. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[Application of fractional laser resurfacing in the treatment of superficial scar]. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fractional radiofrequency for the treatment and reduction of acne scarring: A prospective study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Fractional microneedle radiofrequency versus fractional carbon dioxide laser in the treatment of postburn hypertrophic scars. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Long-Term Clinical and Histological Effects of a Bipolar Fractional Radiofrequency System in the Treatment of Facial Atrophic Acne Scars and Acne Vulgaris in Japanese Patients: A Series of Eight Cases. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Fractionated Er:YAG laser versus fully ablative Er:YAG laser for scar revision: Results of a split scar, double blinded, prospective trial. [2018]

11. India pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Fractional CO2 Laser Resurfacing in Non-hypertrophic Traumatic and Burn Scars. [2020]