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.
What safety data exists for radiofrequency treatment for skin conditions?Radiofrequency treatment, including monopolar and bipolar devices, is considered safe and effective for skin tightening and rejuvenation. Studies have shown it to be comparable to laser resurfacing with potentially faster healing. Pain is a noted adverse effect due to deep penetration. Combined RF and optical energy systems may reduce side effects. RF treatments are established as safe for various dermatologic procedures, though adverse events can vary, especially in individuals with Fitzpatrick skin phototypes IV to VI.12489
What data supports the idea that Radiofrequency Treatment for Skin Conditions is an effective treatment?The available research shows that Radiofrequency Treatment is effective for skin tightening, wrinkle reduction, and improving skin texture. It is a popular choice because it doesn't require surgery and has a shorter recovery time. Studies have found that it works well for skin rejuvenation and scar revision, with results comparable to laser treatments but with faster healing. Additionally, combining RF with light technology can effectively remove hair and reduce wrinkles for all skin types, with fewer side effects. Overall, RF Treatment is a safe and effective option for various skin conditions.12359
Is Radiofrequency-Based treatment a promising treatment for skin conditions?Yes, Radiofrequency-Based treatment is promising for skin conditions. It is a popular and effective option for tightening skin, improving facial and body contours, and treating various skin issues like wrinkles, acne scars, and unwanted hair. It works without surgery, meaning less recovery time and fewer risks.23679
Do I have to stop taking my current medications for the trial?Yes, you may need to stop taking certain medications. The trial excludes participants on systemic steroids, immune modulators, blood thinners, and those who have taken medications that may impair wound healing or affect the study, like oral/topical antihistamines and analgesics. Please consult with the study team for specific guidance.
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 have HS with localized disease in my armpits, of mild to moderate severity, and no active infections.
Exclusion Criteria
I am currently taking medication to modulate my immune system.
I have a bleeding disorder.
I have had keloids or thick scars in the last 10 years.
I currently have an active infection or am being treated for one.
I haven't taken any medication that could affect wound healing in the last year.
I have conditions that make electrothermolysis unsafe for me.
I am unable to understand and give consent for treatment.
I am currently taking systemic steroids.
I am taking blood thinners.
Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
Johns Hopkins School of MedicineBaltimore, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
References
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.
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.
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.
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.
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.
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.
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.
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.
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.