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Radiofrequency-Based treatment
Radiofrequency Treatment for Skin Conditions
N/A
Recruiting
Led By Noori Kim
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Must not have
Participants on immune modulators
Participants with bleeding disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to treat skin conditions using radiofrequency waves.
Who is the study for?
This trial is for adults aged 22-70 with mild to moderate Hidradenitis Suppurativa (HS) localized to the underarms, or healthy individuals. Participants must understand the study and follow procedures, including multiple skin biopsies. Excluded are those on certain medications like blood thinners, immune modulators, systemic steroids; with allergies to anesthetics; active infections; significant medical history; pregnant/nursing women; or a history of severe scarring.
What is being tested?
The study tests radiofrequency-based treatment's effects on human skin in HS patients and healthy subjects. It aims to determine if this method is feasible by observing how it affects treated areas compared to untreated ones.
What are the potential side effects?
Potential side effects may include reactions at the biopsy site such as pain, swelling, bruising or infection. There might also be risks associated with radiofrequency treatment itself like burns or changes in skin sensation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have HS with localized disease in my armpits, of mild to moderate severity, and no active infections.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication to modulate my immune system.
Select...
I have a bleeding disorder.
Select...
I have had keloids or thick scars in the last 10 years.
Select...
I currently have an active infection or am being treated for one.
Select...
I haven't taken any medication that could affect wound healing in the last year.
Select...
I have conditions that make electrothermolysis unsafe for me.
Select...
I am unable to understand and give consent for treatment.
Select...
I am currently taking systemic steroids.
Select...
I am taking blood thinners.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety of skin-RF interactions in axillary skin
Tolerability of skin-RF interactions in axillary skin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy ParticipantsExperimental Treatment1 Intervention
Electrothermolysis treatment using varying levels of RF energies
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,760 Total Patients Enrolled
Noori KimPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 22 and 70 years old.I am willing and able to follow the study's requirements and attend all visits.You are allergic to anesthesia.I am currently taking medication to modulate my immune system.I have a bleeding disorder.I have HS with localized disease in my armpits, of mild to moderate severity, and no active infections.I have not taken any medication that could affect the study, like antihistamines or painkillers.I have had keloids or thick scars in the last 10 years.People who do not follow the study rules.I currently have an active infection or am being treated for one.I haven't taken any medication that could affect wound healing in the last year.I can understand and communicate with my doctor.People with weakened immune systems.I have conditions that make electrothermolysis unsafe for me.I am unable to understand and give consent for treatment.I have not been treated for skin conditions that could affect clinical assessments recently.I am currently taking systemic steroids.I am taking blood thinners.You are unable to complete the strength and feeling tests needed for this study.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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