Abstract
INTRODUCTION: This split-face, double-blind, randomized controlled study investigated the efficacy and safety of using a microneedling radiofrequency (RF) device with polynucleotides (PN) versus RF alone for the treatment of melasma. METHODS: Thirty adult participants with melasma (Fitzpatrick skin types III-V) received three treatments with an invasive, bipolar, pulsed-type microneedling RF device on both sides of the face. The treatment sessions occurred once every 2 weeks. The hemifaces of each participant were designated for treatment and control with PN and normal saline solution (NSS), applied after treatment with RF. Measurements were made of melanin index (MI), erythema index (EI), skin roughness (by the Antera 3D system), modified melasma area severity index (mMASI) for each hemiface, and patients' self-assessed improvement. These occurred at baseline and again following the final treatment (2 weeks and 1, 2, 3, and 6 months after). Mean values were obtained for MI, EI, skin roughness, and mMASI. A generalized estimating equation (GEE) was used to compare the obtained values for the outcome measures across all assessment points. RESULTS: All patients were women (mean age, 43.2 ± 7.0 years). Mixed melasma predominated (61.5%; n = 16), and the mean duration of melasma was 8.9 ± 6.5 years. Twenty-six participants were followed up to the 6-month assessment point. Significant improvements were observed from baseline in MI, skin roughness, and mMASI scores for both the PN and control sides at 6 months, with no statistically significant differences between sides. Patients' self-assessed improvement scores also showed a positive trend. Melasma recurrence was observed in three patients at 2, 3, and 4 months after the last treatment session (10% recurrence rate). CONCLUSIONS: The combination of an invasive, bipolar, pulsed-type microneedling RF with PN is not superior compared with microneedling RF alone in the treatment of melasma. Microneedling RF may be considered as safe and efficacious for the improvement of skin roughness, and as an adjunctive treatment option for melasma. CLINICAL TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov and assigned NCT number TCTR20210804002.