Investigating the effects of radiofrequency treatment on skin conditions

Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin

This study is testing a new radiofrequency treatment on skin conditions, especially for people with hidradenitis suppurativa, to see how well it works and if it's safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05066113 on ClinicalTrials.gov

What this trial studies

This study assesses the effects of radiofrequency-based selective electrothermolysis on human skin, particularly focusing on the axillary area. The minimally invasive procedure aims to target and destroy specific skin structures while minimizing damage to surrounding tissues. Participants, including healthy volunteers and patients with hidradenitis suppurativa, will undergo up to three treatments and skin biopsies to evaluate safety, tolerability, and biological effects. The study will involve clinical assessments, photography, and questionnaires over a four-month period.

Who should consider this trial

Good fit: Ideal candidates include healthy volunteers and patients aged 22 to 70 with mild to moderate hidradenitis suppurativa localized to the axillae.

Not a fit: Patients who are immunocompromised or have contraindications to selective electrothermolysis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing skin conditions with minimal side effects.

How similar studies have performed: While the approach of using radiofrequency for skin conditions is established, this specific application in hidradenitis suppurativa is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. For primary objective: healthy volunteers and HS patients between 22 and 70 years of age.
2. Participants must be healthy enough to undergo multiple skin biopsy in the opinion of the investigator.
3. Participants must provide informed consent.
4. Participants must have the ability and willingness to follow all study procedures, attend scheduled visits, and successfully complete the study.
5. Participants must have the ability to understand and communicate with the investigator.
6. For HS patients, participants will have localized disease to the axillae, mild to moderate severity and no evidence of active infection as assessed by the investigator

Exclusion Criteria:

1. Participants unable to provide informed consent.
2. Recently treated for current skin diseases that would affect clinical evaluation.
3. Known contraindications to selective electrothermolysis treatment.
4. Immunocompromised patients
5. Participants on systemic steroids
6. Participants on immune modulators
7. Participants on blood thinners
8. Participants with bleeding disorders
9. Participants with any active infections or currently treated infections
10. Participants with significant medical history or concurrent illness that the investigator feels is not safe for biopsy or study participation.
11. Noncompliant participants.
12. Pregnant or nursing participants (qualitative human chorionic gonadotropin (hCG) testing will be performed prior to each treatment).
13. Participants with allergy to anesthetics.
14. Participants with a history of keloids or hypertrophic scars within the past 10 years.
15. Participants who have taken oral/topical antihistamines, oral/topical analgesics, and/or other medications that the investigators believe will impact the study.
16. Participants who are currently taking or who have taken in the past 12 months any medications that may impair wound healing, such as systemic retinoids.
17. Participants who cannot undergo motor strength and sensory testing required to assess for adverse events in this study.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Noori Kim — Johns Hopkins University
• Study coordinator: Ruizhi Wang

Conditions Hidradenitis Suppurativa; Healthy Volunteers; Radiofrequency-Based Selective Electrothermolysis; Healthy volunteers