Ignite Creation Date:
2025-12-18 @ 9:50 AM
Ignite Modification Date:
2025-12-18 @ 9:50 AM
Study NCT ID:
NCT05066113
Status:
None
Last Update Posted:
2025-06-11 00:00:00
First Post:
2021-09-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
Sponsor:
None
Organization:
Study Overview
Official Title:
Feasibility Study on Radiofrequency-Based Selective Electrothermolysis to Investigate Its Effects on Human Skin
Status:
None
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: