Efficacy and Safety of Using Noninsulated Microneedle Radiofrequency Alone Versus in Combination with Polynucleotides for the Treatment of Melasma: A Pilot Study

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.

Can Microneedle Fractional Radiofrequency System Treatment Impair the Skin Barrier Function in Chinese Patients? A Prospective Clinical Trial

“…A study comparing non-insulated microneedle radiofrequency alone with non-insulated microneedle radiofrequency in combination with polynucleotides for the treatment of melasma reported that the MI and erythema indices were lower than those at BL [ 17 ]. The treatment was well tolerated by the patient.…”

Update on Melasma—Part II: Treatment

“…Radiofrequency microneedle was reported as an effective treatment for refractory melasma, although no large randomized controlled studies have been performed [115][116][117].…”

Targeting senescent dermal fibroblasts responsible for hyperactive melanocytes in melasma

“…Recent studies have shown that the presence of pendulous melanocytes, which protrude into the dermis from the epidermis in melasma lesional skin, strongly suggests that the disrupted basement membrane cannot support melanocytes firmly in place where they reside in the basal layer [17] . More recently, several pilot studies have reported that restoration of the basement membrane using carbon dioxide lasers and RF significantly improves the clinical outcome of melasma patient treatments [18] …”

“…[17] More recently, several pilot studies have reported that restoration of the basement membrane using carbon dioxide lasers and RF significantly improves the clinical outcome of melasma patient treatments. [18] In summary, melasma is a heterogeneous disease with a high rebound rate and a relative resistance against existing treatment regimens. In addition to classical skin lightening agents that reduce tyrosinase activity, several novel concept-directed treatments aimed at the removal of senescent dermal fibroblasts, the suppression of neovascularization, the inhibition of mast cell-involved inflammation, and the restoration of impaired basement membrane have emerged over the years, such as RF microneedling, intensive pulsed light, and oral tranexamic acid and senolytics, etc, all of which show beneficial results.…”

“…[ 17 ] More recently, several pilot studies have reported that restoration of the basement membrane using carbon dioxide lasers and RF significantly improves the clinical outcome of melasma patient treatments. [ 18 ]…”