RecruitingNot ApplicableNCT05066113

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

Sponsor

Johns Hopkins University

Enrollment

50 participants

Start Date

Aug 15, 2017

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers Hidradenitis Suppurativa

Summary

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

Eligibility

Min Age: 22 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria17

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.

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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.