Radiofrequency Treatment for Skin Conditions

Overseen By Ruizhi Wang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Steroids, Immune modulators, Blood thinners, Antihistamines

Disqualifiers: Immunocompromised, Bleeding disorders, Active infections, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 months

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 4 8 9}

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

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.

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.

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

Group I: Healthy Participants Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective electro-thermolysis in aesthetic medicine: a review. Sadick, NS., Makino, Y.[2005]

New radiofrequency devices effectively treat skin conditions like wrinkles and laxity by remodeling collagen in the dermis without damaging the outer skin layer, leading to minimal recovery time.

These nonsurgical treatments have been successfully used for various applications, including skin rejuvenation, scar revision, and the treatment of acne and vascular lesions, highlighting their versatility and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonablative cutaneous remodeling using radiofrequency devices. Alster, TS., Lupton, JR.[2022]

A study involving 14 subjects demonstrated that a new multisource radiofrequency (RF) treatment protocol significantly improved skin texture, laxity, and wrinkles, with 43% of participants reporting excellent or very good improvement.

The treatment was safe, with minimal downtime and no reported adverse effects, indicating that RF-based procedures can be an effective non-invasive option for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of microneedle radiofrequency (RF), fractional RF skin resurfacing and multi-source non-ablative skin tightening for minimal-downtime, full-face skin rejuvenation. Kaplan, H., Kaplan, L.[2019]

In a study involving 10 subjects aged 18-75, both unipolar and bipolar radiofrequency (RF) treatments were found to be safe and painless, with minimal side effects such as temporary erythema that resolved quickly.

While the treatments showed a trend toward improvement in reducing facial rhytides and laxity, the differences in efficacy between the unipolar and bipolar handpieces were not statistically significant, indicating that both methods may be similarly effective for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unipolar versus bipolar radiofrequency treatment of rhytides and laxity using a mobile painless delivery method. Alexiades-Armenakas, M., Dover, JS., Arndt, KA.[2008]

In a meta-analysis of 43 studies involving 1654 patients with Fitzpatrick skin phototypes IV to VI, the most common adverse event from nonablative laser therapies was postinflammatory hyperpigmentation (PIH) at a rate of 8.1%.

The risk of PIH was notably higher with diode and erbium-doped lasers compared to intense pulsed light and radiofrequency, and it was positively correlated with higher skin phototypes and greater energy delivery during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Nonablative Lasers and Energy-Based Therapies in Subjects with Fitzpatrick Skin Phototypes IV to VI: A Systematic Review and Meta-Analysis. Hu, S., Atmakuri, M., Rosenberg, J.[2022]

Radiofrequency (RF) treatment has been shown to be effective for various noncosmetic skin conditions, including varicose veins and acne, with a total of 54 studies reviewed involving thousands of patients.

RF is a generally noninvasive treatment option that offers a short recovery time and minimal risk of severe side effects, making it a promising alternative for managing cutaneous diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Therapy and Noncosmetic Cutaneous Conditions. Ekelem, C., Thomas, L., Van Hal, M., et al.[2023]

Radiofrequency (RF) treatment shows potential for various aesthetic applications, including body contour improvement, facial rejuvenation, and treatment of conditions like acne scars and rosacea, based on a review of 25 randomized clinical trials.

Despite its promise, the quality of the studies was inconsistent, and there is currently no strong evidence to support RF treatment as superior to existing therapeutic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the evidence level for the use of radiofrequency in aesthetic treatments: A systematic review and meta-analysis. Oliveira Paggiaro, A., Pinheiro, R., Soares, K., et al.[2021]

References

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

Minimally Invasive Approach to Skin Tightening of the Face and Body: Systematic Review of Monopolar and Bipolar Radiofrequency Devices. [2022]

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

The radiofrequency frontier: a review of radiofrequency and combined radiofrequency pulsed-light technology in aesthetic medicine. [2022]

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

Selective electro-thermolysis in aesthetic medicine: a review. [2005]

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

Nonablative cutaneous remodeling using radiofrequency devices. [2022]

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

Combination of microneedle radiofrequency (RF), fractional RF skin resurfacing and multi-source non-ablative skin tightening for minimal-downtime, full-face skin rejuvenation. [2019]

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

Unipolar versus bipolar radiofrequency treatment of rhytides and laxity using a mobile painless delivery method. [2008]

7. England pubmed.ncbi.nlm.nih.gov

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]

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

Radiofrequency Therapy and Noncosmetic Cutaneous Conditions. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of the evidence level for the use of radiofrequency in aesthetic treatments: A systematic review and meta-analysis. [2021]