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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Hidradenitis Suppurativa
• Intervention / Treatment: Device: Radiofrequency-Based treatment

Detailed Description

Radiofrequency (RF)-based selective electrothermolysis is an increasingly utilized minimally invasive technology for several dermatologic conditions, such as epilation, acne vulgaris, and skin rejuvenation, with minimal side effects. This procedure targets and destroys selective cutaneous and subcutaneous structures; therefore, allowing greater control and specificity of treatment area and minimizing destruction to surrounding tissue. Here, the investigators propose to utilize this technology on human axillary skin to establish safety and biologic effects of selective electrothermolysis in this particular area of the skin.

The investigators will assess the tolerability, safety, and histometric changes in skin-radiofrequency interactions in the axillary skin of participants. The investigators will collect skin samples from prospective volunteers and assess for biologic effects in human axillary skin after selective electrothermolysis treatment.

During the four months of study period, Participants in the study will receive clinical assessments, photography, questionnaires, up to 3 treatments of RF-based selective electrothermolysis to pre-selected areas of the axillary skin, up to 2 4-mm skin biopsies for up to 5 study visits.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruizhi Wang; Phone Number: 410-502-7546; Email: rwang@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins School of Medicine
      • Contact: Ruizhi Wang; Phone Number: 410-502-7546; Email: rwang@jhmi.edu
      • Principal Investigator: Noori Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy Participants; Electrothermolysis treatment using varying levels of RF energies

Device: Radiofrequency-Based treatment; RF-based treatments use electrothermolysis to deliver heat energy to targeted structures in the skin, such as hair follicles or glands by the use of insulated needles. The investigators will use radio frequency based treatment on a pre-selected skin area (about 3cm x 3cm or 1 ¼ x 1 ¼ inches in size) on either your left or right underarm that is eligible for assessment, study treatment, and biopsy. Participants will receive clinical assessments, photography, questionnaires, up to 3 treatments of RF-based selective electrothermolysis to pre-selected areas of the axillary skin, up to 2 4-mm skin biopsies for up to 5 study visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of skin-RF interactions in axillary skin	Tolerability will be assessed by number of patients experiencing adverse events grade 2 or higher as defined by the Common Terminology Criteria for Adverse Events.	4 months
Safety of skin-RF interactions in axillary skin	Safety will be assessed by number of patients experiencing adverse events grade 2 or higher as defined by the Common Terminology Criteria for Adverse Events.	4 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Noori Kim, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Healthy volunteers; Hidradenitis Suppurativa; Radiofrequency-Based Selective Electrothermolysis
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: IRB00112812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes