Gulfan Ma Christina B, Wanitphakdeedecha Rungsima, Wongdama Supisara, Jantanapornchai Nuttagarn, Yan Chadakan, Rakchart Sarawalai
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Innovative Skin and Laser Surgery (iSKY) Center, Bangkok, Thailand.
Dermatol Ther (Heidelb). 2022 Jun;12(6):1325-1336. doi: 10.1007/s13555-022-00728-8. Epub 2022 May 11.
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.
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.
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).
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.
This study was registered on ClinicalTrials.gov and assigned NCT number TCTR20210804002.
本半脸、双盲、随机对照研究调查了使用带有多核苷酸（PN）的微针射频（RF）设备与单独使用RF治疗黄褐斑的疗效和安全性。
30名患有黄褐斑的成年参与者（Fitzpatrick皮肤类型III - V）在面部两侧接受了三次侵入性双极脉冲式微针RF设备治疗。治疗疗程每2周进行一次。每位参与者的半脸被指定用PN和生理盐水（NSS）进行治疗和对照，在RF治疗后应用。测量了每个半脸的黑色素指数（MI）、红斑指数（EI）、皮肤粗糙度（通过Antera 3D系统）、改良黄褐斑面积严重程度指数（mMASI）以及患者的自我评估改善情况。这些测量在基线时以及最后一次治疗后（2周以及1、2、3和6个月后）再次进行。获取了MI、EI、皮肤粗糙度和mMASI的平均值。使用广义估计方程（GEE）比较所有评估点上结局指标的获得值。
所有患者均为女性（平均年龄43.2 ± 7.0岁）。混合性黄褐斑占主导（61.5%；n = 16），黄褐斑的平均病程为8.9 ± 6.5年。26名参与者随访至6个月评估点。6个月时，PN侧和对照侧的MI、皮肤粗糙度和mMASI评分较基线均有显著改善，两侧之间无统计学显著差异。患者的自我评估改善评分也呈积极趋势。在最后一次治疗后2、3和4个月，有3名患者出现黄褐斑复发（复发率10%）。
在治疗黄褐斑方面，侵入性双极脉冲式微针RF与PN联合使用并不优于单独使用微针RF。微针RF在改善皮肤粗糙度方面可能被认为是安全有效的，并且可作为黄褐斑的辅助治疗选择。
本研究在ClinicalTrials.gov上注册，分配的NCT编号为TCTR20210804002。
