Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Delphi consensus
研究概览
简要总结
Radiofrequency microneedling (RFMN) combines controlled delivery of radiofrequency energy into the dermis or subcutaneous tissue through arrays of insulated or non-insulated microneedles. This targeted thermal stimulation induces fibroblast (re-)activation leading to collagen remodeling and neocollagenesis, leading to clinical improvement in skin laxity and rhytides. Despite widespread clinical use, recent FDA announcements have highlighted concerns regarding potentially serious complications associated with RFMN treatments. Given this evolving landscape, consensus-based expert guidance is essential to support clinicians in navigating device selection, treatment parameters, patient counselling, and safety protocols. The present Delphi consensus aims to provide structured expert recommendations to address these emerging challenges.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Board-certified in dermatology or plastic surgery,
- •At least five years of clinical experience using energy-based devices,
- •Documented experience of at least 5 years and/or publications related to RFMN
排除标准
- •not meeting inclusion critera
结局指标
主要结局
Delphi consensus
时间窗: 5 months
Following points are items to the Delphi consensus: * Patient selection (characteristics)/Indications * Contraindications * Treatment parameters and techniques, (energies, frequencies, needle type, treatment depth, number of treatments, interval between treatments, etc) * Training requirements * Pre- and post-procedure care
次要结局
未报告次要终点
研究者
Lynhda Nguyen
Dr. med.
Universitätsklinikum Hamburg-Eppendorf