Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
NCT05066113 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-06-11
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
Interventions
- 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Noori Kim · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-08-15
- Primary Completion
- 2027-08-31
- Completion
- 2028-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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