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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of fractional radiofrequency, a type of energy treatment, in reducing scars after breast surgery. The researchers aim to determine if this treatment can safely aid scar healing when applied before surgery. Women planning breast reduction or mastectomy who wish to prevent scars may qualify, provided they do not have conditions like skin disorders or implanted metal in the treatment area. Participants will receive radiofrequency treatment on one side of the surgical area, allowing for a direct comparison between treated and untreated skin. As an unphased trial, this study provides a unique opportunity to explore innovative scar prevention methods before surgery.

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 prior data suggests that fractional radiofrequency is safe for reducing surgical scars?

Research has shown that fractional radiofrequency treatments are generally safe and easy to manage. Studies have found this method effective in reducing acne scars, with no major safety issues reported. Participants in these studies experienced skin improvements, and any side effects were usually minor and temporary, such as mild redness or swelling that disappeared shortly after treatment. While this trial tests fractional radiofrequency for surgical scars, its successful use in other skin treatments suggests it is likely safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fractional radiofrequency (RF) for surgical scars because it offers a unique approach to improving scar healing and appearance. Unlike traditional scar management options such as silicone sheets, steroid injections, or laser therapy, fractional RF delivers targeted energy below the skin's surface, promoting tissue regeneration and improving skin structure. This method not only potentially accelerates healing but also allows for precise treatment of specific areas, which could lead to more uniform and aesthetically pleasing results. By stimulating collagen production and enhancing tissue repair, fractional RF could significantly improve scar outcomes compared to existing treatments.

What evidence suggests that fractional radiofrequency is effective for reducing surgical scars?

Research has shown that fractional radiofrequency (FRF) can effectively reduce scars. One study found that FRF worked as well as strong lasers in treating acne scars, indicating its potential to improve skin appearance. Another study discovered that combining FRF with laser treatment could enhance effectiveness. In this trial, participants will undergo breast reduction or mastectomy, with FRF applied to one side of the surgical area to assess its effectiveness in treating surgical scars. These findings suggest that FRF could play a promising role in improving skin healing and reducing visible scarring. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9291574/

Safety and efficacy of fractional radiofrequency for the ... Results indicated that FRF was as effective as ablative lasers in reducing acne scars (results showed no statistically significant difference between FRF ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12471114/

Comparative Effectiveness and Safety of Fractional Laser ... In contrast, recent network meta-analyses reported that ablative fractional lasers provide greater scar improvement than non-ablative fractional ...

3. apm.amegroups.org apm.amegroups.org/article/view/78473/html

Effectiveness and safety of fractional micro-plasma radio ... This study revealed that fractional micro-plasma radio-frequency treatment combined with ablative fractional CO 2 laser treatment could be more effective in ...

4. academic.oup.com academic.oup.com/asj/article/45/Supplement_1/S23/7958337

The Role of Fractional Radiofrequency in Long-term Acne ... Available treatments for acne scars often demonstrate mild improvement, but are frequently inconsistent or fail to present a dramatic outcome.35 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824000494

Treatment of Atrophic Acne Scarring with Fractional ... Eighty-six patients completed the study. Significant improvements were observed, with a reduction in ECCA scores from 107.21 to 42.27 (P<0.05), demonstrating ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/53/NCT03767153/Prot_SAP_000.pdf

Clinical Evaluation of the Safety and Performance of ... Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency ... Treatment of Acne Scars with Fractional Radiofrequency: ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lsm.23759

Efficacy and safety of fractional microneedle ... FMR is a safe and effective treatment modality for improving facial atrophic acne scars, and the number of FMR treatment sessions and pulse ...