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Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus

Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07443384
Enrollment
30
Registered
2026-03-02
Start date
2026-05-01
Completion date
2026-10-01
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiofrequency Microneedling

Brief 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.

Interventions

OTHERDelphi 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.

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
Delphi consensus5 monthsFollowing 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026