Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color. (SylfirmX)
Status
Conditions
Treatments
Details and patient eligibility
About
The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma. The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients.
Full description
The target population is skin of color patients with melasma. Patients will receive 3 consecutive RFMN treatments over a period of three months. Baseline melasma severity will be measured by the modified Melasma Area and Severity Index (mMASI) score. Endpoints will be mMASI scores at 1 and 3 months post-procedure. Patient reported outcomes will be measured using the melasma quality of life (MelasQOL) validated patient questionnaire at screening and at both follow up visits. The long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Males or females, at least 18 years of age
- Fitzpatrick skin types IV-VI
- Clinically diagnosed melasma
- No topicals (retinol, vitamin C serum, etc) for 6 weeks before Visit 1 (with exception of sunscreen)
Exclusion criteria
- is currently pregnant or planning to conceive during the study period
- is using topical or oral therapy or other treatment for melasma
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Rothy Rim
Data sourced from clinicaltrials.gov
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