Radiofrequency MicroneedlingNCT07443384
Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus
An observational study of Radiofrequency Microneedling, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Radiofrequency microneedling (RFMN) combines controlled delivery of radiofrequency energy into the dermis or subcutaneous tissue through arrays of insulated or non-insulated microneedles. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiofrequency Microneedling
- What is being tested?
- Delphi consensus on radiofrequency microneedling treatment for skin laxity
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Oct 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: see inclusion/ exclusion criteria
Who may be able to join
- 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
Who cannot join
- not meeting inclusion critera
About this study
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.
- Conditions
- Radiofrequency Microneedling
- Being tested
- Delphi consensus on radiofrequency microneedling treatment for skin laxity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi consensus on radiofrequency microneedling treatment for skin laxityOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency MicroneedlingStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynhda Nguyen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443384
- Sponsor's protocol ID
- 01/26
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Associated With Radiofrequency Microneedling in Dermatology: a Delphi Consensus
- ClinicalTrials.gov ID
- NCT07443384
- Acronym / sponsor ID
- 01/26
- Conditions
- Radiofrequency Microneedling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- see inclusion/ exclusion criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- not meeting inclusion critera
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi consensus on radiofrequency microneedling treatment for skin laxityA 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. | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiofrequency Microneedling, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delphi consensus (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.