Sylfirm X Radiofrequency Microneedling for Melasma

This study is testing a device called Sylfirm X radiofrequency microneedling to see how well and how safely it treats melasma (a skin condition causing dark patches). Researchers want to see if the Sylfirm X device can improve skin quality, tone, and pigment. They will measure success by how accurately a blinded investigator can identify post-treatment photos compared to baseline photos after 28 days. You may be able to join if you are a healthy woman between 18 and 70 years old, have melasma, and are willing to have the treatment and follow the study schedule. This study plans to enroll 90 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 90 healthy women. It is designed to evaluate the efficacy and safety of the Sylfirm X device.
What's involved
You would receive RF microneedling treatment and need to follow a schedule for treatments, follow-up appointments, and post-treatment instructions.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 28 days after treatment.

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NCT06415435

Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma

UNKNOWN
NAAges 18–70InterventionalTreatment
Benev Company, Inc.
~90 participants
Updated 2024-05-16 on ClinicalTrials.gov
What's tested:Radiofrequency Microneedling

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100%
Measured over 28 days
Melasma
3 sites across 3 states
California1
North Carolina1
Texas1

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  • Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100%28 days

    Success criteria: 80% accuracy in identifying the baseline photo from post-treatment photos.