RECRUITING

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

Conditions

Hidradenitis Suppurativa Healthy Volunteers Radiofrequency-Based Selective Electrothermolysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2017-08-15

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05066113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Ruizhi Wang

CONTACT

410-502-7546

rwang@jhmi.edu

Principal Investigator

Noori Kim

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Noori Kim, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-15

Study Completion Date2027-08

Study Record Updates

Study Start Date2017-08-15

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Radiofrequency-Based Selective Electrothermolysis
Hidradenitis Suppurativa
Healthy volunteers

Additional Relevant MeSH Terms

Hidradenitis Suppurativa
Healthy Volunteers