A Multi-Center, Open-Label, Prospective Study of the Sylfirm X Device for the Treatment of Melasma
Benev Company, Inc.
Summary
Microneedling radiofrequency technology has been shown in clinical studies to improve skin quality, tone, pigment, and to treat various skin conditions related to aging. The purpose of this study is to evaluate efficacy and safety of Sylfrim X device for the treatment of melasma.
Eligibility
- Age range
- 18–70 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subject must be able to read, understand and sign informed consent form. 2. Healthy females, 19 and older 3. Fitzpatrick I-VI 4. Has melasma 5. Willing to have RF microneedling treatment and able to adhere to treatments, follow up schedule, and post-treatment instructions 6. Willing to have limited sun exposure and use sunscreen on treatment area everyday for duration of study 7. Willing to have photographs taken of treatment area and agree to use of photographs 8. Willing to refrain from using topical corticosteroids, or retinoids 9. Agree to undergo procedure in treat…
Interventions
- DeviceRadiofrequency Microneedling
Sylfirm X radiofrequency microneedling device
Locations (3)
- Scripps HealthLa Jolla, California
- Dermatology, Laser & Vein Specialists of the Carolinas, PLLCCharlotte, North Carolina
- Refresh DermatologyHouston, Texas