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

Launched by JOHNS HOPKINS UNIVERSITY · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called radiofrequency-based selective electrothermolysis, which aims to see how it affects skin health and conditions like Hidradenitis Suppurativa (HS). The researchers are looking for healthy volunteers and HS patients, aged 22 to 70, who are able to undergo a few skin biopsies and are willing to follow the study guidelines. Participants should not have any current infections or serious health issues that could affect their safety during the study.

If you decide to participate, you can expect to attend scheduled visits where the treatment will be applied, and you will be monitored for any reactions. It’s important to note that certain individuals, like those who are pregnant or have specific medical conditions, may not be eligible for this study. Your participation will help researchers understand how this treatment works, which could lead to better options for skin health in the future.

Gender

ALL

Eligibility criteria

• 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.