Radiofrequency Treatment for Skin Conditions

Recruiting in Palo Alto (17 mi)

Overseen by Noori Kim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 4 Jurisdictions

Trial Summary

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.

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}

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.

Trial 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 (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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins School of Medicine Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

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] Radiofrequency treatment is a relatively new and increasingly popular option for patients desiring skin tightening and an improvement in facial or body contour without undergoing an excisional surgical procedure. A systematic review of the literature was performed to investigate the safety and efficacy of monopolar and bipolar radiofrequency devices for facial and body rejuvenation.

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] Radiofrequency (RF) and combined RF light source technologies have established themselves as safe and effective treatment modalities for several dermatologic procedures, including skin tightening, hair and leg vein removal, acne scarring, skin rejuvenation, and wrinkle reduction. This article reviews the technology, clinical applications, and recent advances of RF and combined RF light/laser source technologies in aesthetic medicine.

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

Selective electro-thermolysis in aesthetic medicine: a review. [2005] The use of radiofrequency (RF) for selective electro-thermolysis has been found to produce a highly efficient thermal effect on biological tissue. Different from optical energy, RF energy is dependent on the electrical properties of the tissue rather than on concentration of chromophores in the skin for selective thermal destruction of targeted sites. Good results have been obtained with systems that use RF current alone for skin resurfacing, with efficacy comparable to laser resurfacing but with potentially more rapid healing. A related adverse effect is pain accompanying the procedure, due to a high depth of penetration. Another technology integrates RF energy together with optical energy (using lower energies of both forms of energies). These systems have shown efficacy in hair removal for all hair colors and skin types, as well as wrinkle reduction; and may reduce the risk of side effects associated with either RF or optical treatments alone. This article discusses the properties of electrical current in medicine and reviews the studies to date that have evaluated RF energy for dermatological applications.

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

Nonablative cutaneous remodeling using radiofrequency devices. [2022] In recent years, several new radiofrequency devices have been introduced for treatment of a variety of skin conditions, particularly, skin wrinkling and laxity. These nonsurgical systems induce tissue tightening and contour changes through dermal collagen remodeling without disruption of the overlying epidermis, obviating a significant recovery period or risk of serious adverse sequelae. As such, radiofrequency-based systems have been used successfully for nonablative skin rejuvenation, atrophic scar revision, and treatment of unwanted hair, vascular lesions, and inflammatory acne.

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] In the recent years, there is a growth in demand for radiofrequency (RF)-based procedures to improve skin texture, laxity and contour. The new generation of systems allow non-invasive and fractional resurfacing treatments on one platform.

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

Unipolar versus bipolar radiofrequency treatment of rhytides and laxity using a mobile painless delivery method. [2008] Previous studies have shown that radiofrequency (RF) energy is a safe and effective treatment for rhytide-reduction.

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] Although there is an abundance of literature on nonablative laser and energy-based therapies for the management of skin conditions, adverse events are inconsistently addressed and range widely across studies. Fitzpatrick skin phototypes (SPTs) IV to VI are believed to be at higher risk.

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

Radiofrequency Therapy and Noncosmetic Cutaneous Conditions. [2023] The need for noninvasive methods in treatment of cutaneous disease has continued to evolve exponentially. Amidst the search for technologies, radiofrequency (RF) has proven efficacious in numerous skin disease processes. Although RF is well known for its cosmetic utility, its mechanism is valued in the treatment of many noncosmetic cutaneous conditions of various etiologies.

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] Radiofrequency (RF) is a non-invasive or minimally invasive procedure with a low risk of complications. It has been employed for several aesthetic purposes.