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NCT07443384

Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus

Sponsor: Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-05-01

Completion Date

2026-10-01

Last Updated

2026-03-02

Healthy Volunteers

Not specified

Interventions

OTHER

Delphi consensus on radiofrequency microneedling treatment for skin laxity

A survey will be developed and send to the members of the European Society for Lasers and Energy-based Devices (ESLD) and those of the Laser and Energy-Based Devices Task Force of the European Academy of Dermatology and Venereology (EADV). The survey includes questions about patient selection criteria, pre- and post-care recommendations, training requirements, management of complications. Based in the survey, a Delphi consensus statement will be developed with selected experts based on predefined criteria. Potential participants will be invited via email. Participation is voluntary.