| Objective Melasma is an acquired hyperpigmented skin disease of the face that occurs predominantly in women.Its etiology and pathogenesis are complex,the success rate of treatment is low,and the recurrence rate is high.As a new physical osmopromotion method,microneedles have been universally used these days to improve the transdermal penetration of drugs,which can penetrate the skin barrier while avoiding contact with important nerves and capillaries in the epidermis.Current studies have shown that microneedle,as an adjuvant treatment for melasma,is often combined with topical drugs,oral drugs,laser,etc.,and has obtained promising efficacy.This systematic review was conducted to search the relevant literature and further analyze the efficacy and safety of microneedle in the adjuvant treatment of melasma,in order to improve the treatment effect of melasma.Methods:Web of Science,MEDLINE,Pub Med,Embase,Wanfang database,China National Knowledge Infrastructure(CNKI),and VIP database were searched by computer from the establishment of the database to January2023.All randomized controlled trials(RCTS)on the use of microneedles as an adjuvant therapy for melasma were searched,and the references of included studies were further searched and screened to prevent missing selections.Documentation was reviewed against predefined eligibility and exclusion criteria,and the quality of included trials was assessed and data retrieved.Revman5.4 systematic review software was used for Metaanalysis.Results:A total of 16 articles were included in this systematic review,including 13 randomized controlled trials and 3 randomized split-face controlled trials,with a total of 939 patients,including 478 patients in the experimental group and 507 patients in the control group.Results were as follows:1.Compared with baseline,the MASI score of patients with chloasma after adjuvant microneedle therapy improved over time,and the improvement was mild to moderate at 4 weeks(SMD=0.49,95%CI [0.25,0.74],P < 0.0001).There was a moderate improvement from baseline at 8weeks(SMD=0.72,95%CI [0.49,0.95],P < 0.00001).Compared with baseline,there was a significant improvement at 12 and 16 weeks(12weeks,SMD=1.30,95%CI [1.10,1.51],P < 0.00001),(16 weeks,SMD=1.03,95%CI [0.77,1.30],P < 0.00001).Maximum improvement from baseline SMD=1.78,95%CI [1.45,2.12],P < 0.00001).2.In patients with melasma,the MASI scores of the microneedleassisted combined with laser therapy and laser therapy alone improved over time compared with baseline.At 4 weeks,the MASI score of the combined treatment was slightly improved compared with that of laser therapy alone,and the difference was not statistically significant(SMD=0.22,95%CI [-0.15,0.60],P=0.24).Compared with the baseline,the combination therapy had a greater improvement in MASI score at 12 and 24 weeks(12 weeks,SMD=0.81,95%CI [0.55,1.07],P < 0.00001),(24 weeks,SMD=0.70,95%CI [0.32,1.08],P=0.0003).3.Compared with baseline,the MASI score of patients with chloasma improved over time with microneedle-assisted combined oral TXA treatment and oral TXA treatment alone.At 8 weeks,the MASI score of combined treatment was slightly improved compared with that of oral TXA therapy alone did not have a statistical significance(SMD=0.34,95%CI[0.01,0.68],P=0.05);Compared with oral TXA alone,the combination therapy had a mild to moderate improvement in MASI score at 16 weeks(SMD=0.44,95%CI [0.11,0.78],P=0.010),and a moderate to high improvement in MASI score at 24 weeks(SMD=0.44,95%CI [0.11,0.78],P=0.010).(SMD=0.74,95%CI [0.44,1.05],P < 0.00001).4.The MASI scores of the patients with chloasma were improved over time compared with baseline.At 4 and 8 weeks,the MASI scores of the combined treatment were not significantly improved compared with that of the topical treatment alone(4 weeks,SMD=0.05,95%CI [-0.36,0.46];At week 8,SMD=0.17,95%CI [-0.25,0.59],P=0.42),and at week 12,SMD=0.85,95%CI [0.45,1.25],P < 0.0001.5.For the same drug,the MASI scores of melasma patients treated with microneedle adjuvant therapy and microinjection were improved over time compared with baseline,and the MASI scores of combined treatment were moderately improved compared with baseline at 12 weeks(SMD=0.58,95%CI [0.13,1.03],P=0.01).6.Patients treated with microneedle were significantly more likely to be treated with a micropipette compared to those in the control group(OR=4.40,95%CI [2.20,8.78],P < 0.0001).7.Patients were more satisfied with the microprocessor-based therapy compared to the control group(OR=3.88,95%CI [2.45,6.15],P < 0.00001).8.There was no significant difference in the occurrence of pruritus(RR=0.65,95%CI [0.04,11.63],P=0.77)and burning sensation(RR=0.87,95%CI [0.42,1.81],P=0.70)between the control group and the microneedle-assisted group.95%CI [0.50,1.69],P=0.80)and PIH(RR=0.68,95%CI [0.25,1.84],P=0.45),but the difference was not statistically significant.Conclusions:1.The MASI score of patients with melasma who received microneedle-assisted treatment improved over time compared to the baseline,with mild to moderate improvement observed at 4 weeks,and the efficacy was proportional to the treatment time.2.The MASI score of patients with melasma improved over time with microneedle-assisted combination therapy compared to monotherapy,and the improvement was greater with combination therapy.3.For the same medication,microneedle-assisted administration was more effective in improving melasma than microinjection administration at week 12.4.The efficacy and patient satisfaction of microneedle-assisted treatment for melasma were significantly higher than those of the control group. |
