Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma (NCT06415435) | Clinical Trial Compass
RecruitingNot Applicable
Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma
United States90 participantsStarted 2023-05-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Subject must be able to read, understand and sign informed consent form.
✓. Healthy females, 19 and older
✓. Fitzpatrick I-VI
✓. Has melasma
✓. Willing to have RF microneedling treatment and able to adhere to treatments, follow up schedule, and post-treatment instructions
✓. Willing to have limited sun exposure and use sunscreen on treatment area everyday for duration of study
✓. Willing to have photographs taken of treatment area and agree to use of photographs
✓. Willing to refrain from using topical corticosteroids, or retinoids
Exclusion criteria
✕. Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study.
✕. Any type of prior cosmetic treatment to the target area within 3 months of study participation, such as laser/light procedures, and those used for general aesthetic correction, neuromodulators, facial peel, lightening creams, or facial surgery.
✕. Any fillers within 3 months prior to enrollment or during the study.
✕. 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.
What they're measuring
1
Percentage of photos accurately identified as post-treatment photo vs. baseline by a blind investigator from 0-100%
✕. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
✕. . Pregnant and/or breastfeeding or planning to become pregnant.
✕. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
✕. Any use of any medication that is known to increase sensitivity to light or hypersensitivity to light exposure according to the Investigator's discretion.