Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus

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.

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Key information

Conditions

Radiofrequency Microneedling

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

not meeting inclusion critera

Treatment and study plan

Delphi consensus on radiofrequency microneedling treatment for skin laxity

Other

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.

Primary outcomes

Delphi consensus

Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 2, 2026
Registry last updated: Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.