Hidradenitis SuppurativaNCT05066113
Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
A study testing Radiofrequency-Based treatment in people with Hidradenitis Suppurativa and Healthy Volunteers, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to assess the effect of radiofrequency (RF)-based treatment on skin and skin conditions. Read more about this study
- Who is it for?
- Ages 22 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa, Healthy Volunteers
- What is being tested?
- Radiofrequency-Based treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 8 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
- 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.
- Participants who cannot undergo motor strength and sensory testing required to assess for adverse events in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
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.
- Conditions
- Hidradenitis Suppurativa, Healthy Volunteers
- Being tested
- Radiofrequency-Based treatment
- Keywords
- Radiofrequency-Based Selective Electrothermolysis, Hidradenitis Suppurativa, Healthy volunteers
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency-Based treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Electrothermolysis treatment using varying levels of RF energies Receives: Device: Radiofrequency-Based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start15 Aug 2017
- Primary completion8 Mar 2026
- Study completion8 Mar 2026
Why it stopped: Funding were insufficient to complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noori Kim, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066113
- Sponsor's protocol ID
- IRB00112812
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
- ClinicalTrials.gov ID
- NCT05066113
- Acronym / sponsor ID
- IRB00112812
- Conditions
- Hidradenitis Suppurativa, Healthy Volunteers
- Keywords
- Radiofrequency-Based Selective Electrothermolysis, Hidradenitis Suppurativa, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding were insufficient to complete
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to assess the effect of radiofrequency (RF)-based treatment on skin and skin conditions.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Device: Radiofrequency-Based treatmentElectrothermolysis treatment using varying levels of RF energies |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency-Based treatmentRF-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. | Device | Healthy Participants |
Primary outcome
Tolerability of skin-RF interactions in axillary skin
Time frame: 4 months
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.
Safety of skin-RF interactions in axillary skin
Time frame: 4 months
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.
Results and safety
The study was stopped early (reason given: Funding were insufficient to complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noori Kim principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency-Based treatment in people with Hidradenitis Suppurativa and Healthy Volunteers, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding were insufficient to complete). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of skin-RF interactions in axillary skin (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.