Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

not meeting inclusion critera

Trial population

see inclusion/ exclusion criteria

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Delphi consensus on radiofrequency microneedling treatment for skin laxity

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Delphi consensus

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

Time frame
5 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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