50 Participants Needed

Radiofrequency Treatment for Skin Conditions

RW
Overseen ByRuizhi Wang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants not be on certain medications, such as systemic steroids, immune modulators, blood thinners, and medications that may impair wound healing. If you are taking these, you may need to stop them to participate.

What data supports the effectiveness of the radiofrequency treatment for skin conditions?

Research shows that radiofrequency treatment is effective for skin tightening, wrinkle reduction, and improving skin texture without surgery. It works by heating the skin to stimulate collagen production, which helps in rejuvenating the skin and improving its appearance.12345

Is radiofrequency treatment safe for skin conditions?

Radiofrequency treatment is generally considered safe for skin conditions, with studies showing it is effective for skin tightening, wrinkle reduction, and other dermatologic procedures. However, some people may experience pain during the procedure due to the depth of penetration.12367

How is radiofrequency treatment different from other treatments for skin conditions?

Radiofrequency treatment is unique because it uses energy to heat the deeper layers of the skin, promoting collagen remodeling and skin tightening without surgery or significant recovery time. This non-invasive approach is effective for both cosmetic and noncosmetic skin conditions, offering a safer alternative to more invasive procedures.12489

What is the purpose of this trial?

This research is being done to assess the effect of radiofrequency (RF)-based treatment on skin and skin conditions.

Research Team

NK

Noori Kim, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults aged 22-70 with mild to moderate Hidradenitis Suppurativa (HS) localized to the underarms, or healthy individuals. Participants must understand the study and follow procedures, including multiple skin biopsies. Excluded are those on certain medications like blood thinners, immune modulators, systemic steroids; with allergies to anesthetics; active infections; significant medical history; pregnant/nursing women; or a history of severe scarring.

Inclusion Criteria

I am between 22 and 70 years old.
I am willing and able to follow the study's requirements and attend all visits.
I have HS with localized disease in my armpits, of mild to moderate severity, and no active infections.
See 3 more

Exclusion Criteria

Participants with significant medical history or concurrent illness that the investigator feels is not safe for biopsy or study participation
You are allergic to anesthesia.
I am currently taking medication to modulate my immune system.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 3 treatments of RF-based selective electrothermolysis to pre-selected areas of the axillary skin

4 months
Up to 5 study visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Radiofrequency-Based treatment
Trial Overview The study tests radiofrequency-based treatment's effects on human skin in HS patients and healthy subjects. It aims to determine if this method is feasible by observing how it affects treated areas compared to untreated ones.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Healthy ParticipantsExperimental Treatment1 Intervention
Electrothermolysis treatment using varying levels of RF energies

Radiofrequency-Based treatment is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Radiofrequency-Based Treatment for:
  • Skin rejuvenation
  • Wrinkle reduction
  • Acne treatment
  • Body contouring
🇺🇸
Approved in United States as RF Treatment for:
  • Facial skin tightening
  • Skin rejuvenation
  • Acne treatment
  • Body contouring
🇨🇦
Approved in Canada as Selective Electrothermolysis for:
  • Skin rejuvenation
  • Wrinkle reduction
  • Acne treatment
🇯🇵
Approved in Japan as Radiofrequency-Based Treatment for:
  • Skin laxity
  • Facial skin tightening
  • Acne treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Findings from Research

Monopolar and bipolar radiofrequency devices have been shown to effectively improve skin laxity in both facial and body treatments, based on a systematic review of 23 clinical studies.
While both types of devices have an acceptable safety profile, monopolar devices are associated with a higher rate of major complications compared to bipolar devices, which tend to have mostly minor and transient side effects.
Minimally Invasive Approach to Skin Tightening of the Face and Body: Systematic Review of Monopolar and Bipolar Radiofrequency Devices.Rohrich, RJ., Schultz, KP., Chamata, ES., et al.[2022]
Radiofrequency (RF) technologies are proven to be safe and effective for various dermatological treatments, including skin tightening and wrinkle reduction.
Recent advances in RF and combined RF light/laser technologies enhance their clinical applications in aesthetic medicine, making them versatile options for procedures like acne scarring and hair removal.
The radiofrequency frontier: a review of radiofrequency and combined radiofrequency pulsed-light technology in aesthetic medicine.Sadick, N., Sorhaindo, L.[2022]
Radiofrequency (RF) energy is effective for selective electro-thermolysis, providing comparable results to laser resurfacing for skin treatments, but with potentially faster healing times.
Combining RF energy with optical energy enhances treatment efficacy for hair removal and wrinkle reduction across various skin types and colors, while also reducing the risk of side effects associated with each treatment alone.
Selective electro-thermolysis in aesthetic medicine: a review.Sadick, NS., Makino, Y.[2005]

References

Minimally Invasive Approach to Skin Tightening of the Face and Body: Systematic Review of Monopolar and Bipolar Radiofrequency Devices. [2022]
The radiofrequency frontier: a review of radiofrequency and combined radiofrequency pulsed-light technology in aesthetic medicine. [2022]
Selective electro-thermolysis in aesthetic medicine: a review. [2005]
Nonablative cutaneous remodeling using radiofrequency devices. [2022]
Combination of microneedle radiofrequency (RF), fractional RF skin resurfacing and multi-source non-ablative skin tightening for minimal-downtime, full-face skin rejuvenation. [2019]
Unipolar versus bipolar radiofrequency treatment of rhytides and laxity using a mobile painless delivery method. [2008]
Adverse Events of Nonablative Lasers and Energy-Based Therapies in Subjects with Fitzpatrick Skin Phototypes IV to VI: A Systematic Review and Meta-Analysis. [2022]
Radiofrequency Therapy and Noncosmetic Cutaneous Conditions. [2023]
Evaluation of the evidence level for the use of radiofrequency in aesthetic treatments: A systematic review and meta-analysis. [2021]
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