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TerminatedNCT05066113Updated Jun 9, 2026

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

An interventional study of Radiofrequency-Based treatment in Hidradenitis Suppurativa and Healthy Volunteers, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 22 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Basic science

Why this study was terminated
Funding were insufficient to complete

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Aug 2017, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
22 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hidradenitis Suppurativa
  • Healthy Volunteers

Keywords

  • Radiofrequency-Based Selective Electrothermolysis
  • Hidradenitis Suppurativa
  • Healthy volunteers
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 23 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Healthy Participants

    Electrothermolysis treatment using varying levels of RF energies

    Device: Radiofrequency-Based treatment

Interventions

  • DeviceRadiofrequency-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

07

Study locations

1 site
  • Johns Hopkins School of Medicine
    Baltimore, Maryland 21287, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05066113
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Oct 4, 2021
Start date
Aug 15, 2017
Primary completion
Mar 8, 2026
Completion
Mar 8, 2026
Last update
Jun 9, 2026

Study contacts

Noori Kim
principal investigator · Johns Hopkins University

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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