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Procedure

Radiofrequency Microneedling for Melasma

N/A
Recruiting
Research Sponsored by Benev Company, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy females, 19 and older, Fitzpatrick I-VI, with melasma
Be older than 18 years old
Must not have
Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity
Significant skin conditions in the treated areas or inflammatory skin conditions prior to treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

"This trial aims to test if the Sylfrim X device, which uses microneedling radiofrequency technology, is effective and safe for treating melasma, a skin condition that causes dark patches

Who is the study for?
This trial is for individuals with melasma, a condition that causes brown patches on the skin. Participants should be seeking treatment to improve their skin's appearance.Check my eligibility
What is being tested?
The study is testing the Sylfirm X device, which uses microneedling radiofrequency technology to potentially enhance skin quality and reduce pigmentation issues associated with melasma.See study design
What are the potential side effects?
Potential side effects may include temporary redness, swelling at the treatment site, minor bleeding from needle pricks, and possible discomfort during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy woman, 19 or older, with any skin type, who has melasma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used prescription skin products or sensitive skin products on the treatment area recently.
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I have serious skin issues or inflammation in the areas to be treated.
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I am not pregnant, breastfeeding, planning to become pregnant, or suffering from serious illnesses.
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I am taking medication that makes my skin more sensitive to light.
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I have not been in a drug or device trial for my condition in the last 3 months.
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I haven't used hormonal treatments for melasma in the last 6 months.
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I have a history of connective tissue disease or skin conditions worsened by heat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100%
Secondary outcome measures
Change in Modified Melasma Area and Severity Index (mMASI) scale measured by investigator (range 0-24), a lower score indicating clearer skin.
Percentage of subjects with an increase in satisfaction level assessed from Melasma Quality of Life questionnaire (MELQoL) after treatment compared to baseline
Statistical improvement of investigator Global Aesthetic Improvement Scale (GAIS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sylfirm X Treatment with SunscreenExperimental Treatment1 Intervention
Group II: No Treatment, Sunscreen OnlyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Microneedling
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Benev Company, Inc.Lead Sponsor
~42 spots leftby Jul 2025