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

NCT05066113 | Terminated FDA Device

• 1 other identifier: IRB00112812
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hidradenitis Suppurativa; Healthy Volunteers

Keywords

Radiofrequency-Based Selective Electrothermolysis; Hidradenitis Suppurativa; Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthy Participants

EXPERIMENTAL

Electrothermolysis treatment using varying levels of RF energies

Device: Radiofrequency-Based treatment

Interventions

Radiofrequency-Based treatment DEVICE

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.

Healthy Participants

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For primary objective: healthy volunteers and HS patients between 22 and 70 years of age.
• Participants must be healthy enough to undergo multiple skin biopsy in the opinion of the investigator.
• Participants must provide informed consent.
• Participants must have the ability and willingness to follow all study procedures, attend scheduled visits, and successfully complete the study.
• Participants must have the ability to understand and communicate with the investigator.
• 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

You may not qualify if:

• Participants unable to provide informed consent.
• Recently treated for current skin diseases that would affect clinical evaluation.
• Known contraindications to selective electrothermolysis treatment.
• Immunocompromised patients
• Participants on systemic steroids
• Participants on immune modulators
• Participants on blood thinners
• Participants with bleeding disorders
• Participants with any active infections or currently treated infections
• Participants with significant medical history or concurrent illness that the investigator feels is not safe for biopsy or study participation.
• Noncompliant participants.
• Pregnant or nursing participants (qualitative human chorionic gonadotropin (hCG) testing will be performed prior to each treatment).
• Participants with allergy to anesthetics.
• Participants with a history of keloids or hypertrophic scars within the past 10 years.
• Participants who have taken oral/topical antihistamines, oral/topical analgesics, and/or other medications that the investigators believe will impact the study.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Noori Kim

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled to test for the tolerability, safety, and histometric changes in skin-RF interactions in axillary skin. RF-based selective electrothermolysis will be administered to skin of healthy volunteers and Hidradenitis Suppurativa (HS) patients at varying depth, intensity, and time.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: October 4, 2021
• Study Start: August 15, 2017
• Primary Completion: March 8, 2026
• Study Completion: March 8, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)