Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.

A Prospective Study of the Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.

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.

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.

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