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

Primary Purpose

Hidradenitis Suppurativa, Healthy Volunteers

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency-Based treatment
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hidradenitis Suppurativa focused on measuring Radiofrequency-Based Selective Electrothermolysis, Hidradenitis Suppurativa, Healthy volunteers

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Participants

Arm Description

Electrothermolysis treatment using varying levels of RF energies

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
June 29, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05066113
Brief Title
Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
Official Title
Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa, Healthy Volunteers
Keywords
Radiofrequency-Based Selective Electrothermolysis, Hidradenitis Suppurativa, Healthy volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Participants
Arm Type
Experimental
Arm Description
Electrothermolysis treatment using varying levels of RF energies
Intervention Type
Device
Intervention Name(s)
Radiofrequency-Based treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability of skin-RF interactions in axillary skin
Description
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
Title
Safety of skin-RF interactions in axillary skin
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruizhi Wang
Phone
410-502-7546
Email
rwang@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noori Kim
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruizhi Wang
Phone
410-502-7546
Email
rwang@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Noori Kim, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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