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Melasma therapy remains challenging due to limited effectiveness, side effects, and relapses. Topical tranexamic acid (TXA) is promising but requires further research to optimize its formulation. Alongside the therapeutic benefit of fractional CO2 laser (FCL) in melasma, FCL and microneedling (MN) are recognized methods for transepidermal drug delivery. Nanotechnology-based topicals can enhance drug penetration and reduce side effects. Objectives were to evaluate and compare the effectiveness of combined FCL- or MN-assisted transepidermal delivery of TXA 3% gel and FCL monotherapy versus nanotechnology-based TXA 1% microemulsion monotherapy in melasma treatment. Fifty-two melasma females were divided randomly into three groups (A, B & C) for a five-month treatment. Group A ( n  = 20), using a split-face design, received FCL on the right side (A1) and MN on the left (A2), both with TXA 3% gel applied post-session and daily. Group B ( n  = 21), also with a split-face design, received FCL with TXA 3% gel post-session only on the right side (B1), while the left side (B2) received FCL alone. Group C ( n  = 11) received TXA 1% microemulsion daily for the whole face. Evaluations included clinical, dermoscopic, and immunohistochemical SOX10 assessments, with a three-month follow-up. All groups showed a significant reduction of Hemi Melasma Area and Severity Index (Hemi-MASI), dermoscopic, and SOX10 immunoreactivity scores. Groups A1, A2, and C exhibited greater improvement compared to B1 and B2. No recurrence occurred during follow-up. Concluding that TXA 1% microemulsion is effective and safe, procedure-free monotherapy with outcomes comparable to FCL- and MN-assisted TXA 3% gel delivery for melasma.

Purpose This study aimed to evaluate the efficacy of amber photobiomodulation (PBM) compared to topical tranexamic acid (TXA) for the treatment of melasma. Methods In a non-inferiority randomized controlled trial, 21 women were randomized to either active PBM with placebo cream ( n  = 10) or sham PBM with 5% liposomal TXA cream ( n  = 11) for 12 weeks. A noninferiority study was chosen based on the hypothesis that PBM could offer comparable efficacy to TXA with fewer adverse effects. The primary outcome was the Melasma Area and Severity Index (MASI). Secondary outcomes included corneomelametry, Physician’s Global Assessment (PGA), quality of life measured by the MELASQoL questionnaire, and adverse events. Results No significant differences were observed in the MASI or PGA scores, within or between groups. However, the study was underpowered (51% power) due to early termination and is thus considered a pilot. A transient increase in pigmentation intensity was observed in the TXA groups at week six. Despite the lack of clinical improvement, both groups sustained improvements in quality of life. The adverse events were mild, with PBM associated with warmth and TXA with a burning sensation. The absence of MASI reduction can be attributed to the elevated environmental temperatures during the study period, consistently above historical averages. In addition, both PBM and TXA may have limited efficacy in cases of chronic or dermal melasma. Conclusion Although no significant clinical changes were detected in MASI or PGA, both treatments improved the quality of life, highlighting the importance of patient-reported outcomes. Given the small sample size and potential environmental confounders—particularly elevated temperatures during the study period—definitive conclusions about treatment efficacy cannot be drawn. Future studies should consider optimized protocols and/or combination therapies. Trial Registration: Clinical Trials No. NCT05326997, April 14th 2022.

This study was aimed at evaluating the efficacy of Tranexamic Acid (TA) mesotherapy versus cysteamine 5% cream in the treatment of melasma. This single-blind, randomized clinical trial was conducted among 54 subjects between 2018 and 2019. Cysteamine 5% cream group was instructed to apply the cream on the melasma lesions 30 min before bed for 4 consecutive months. Conversely, 0.05 mL (4 mg/mL) TA mesotherapy was performed by a physician every 4 weeks until 2 months. The severity of melasma was evaluated using both Dermacatch® device and the modified Melasma Area Severity Index (mMASI). The most remarkable improvement rate was observed in the TA group at the third visit based on mMASI and Dermacatch® values at 47% and 15% in turn. The mMASI scores were substantially improved in both groups at the second visit (cysteamine vs TA 8.48 ± 2.34 and 7.03 ± 3.19; P  = 0.359) and third visit (cysteamine vs TA 6.32 ± 2.11 and 5.52 ± 2.55; P  = 0.952) as compared to baseline (cysteamine vs TA: 11.68 ± 2.70 and 10.43 ± 2.69). Dermacatch® values were significantly declined at the second and third visits (cysteamine vs TA 42.54 ± 12.84 and 38.75 ± 9.80, P  = 0.365; 40.74 ± 12.61 and 36.17 ± 10.3, P  = 0.123, respectively) compared with baseline (cysteamine vs TA 45.76 ± 13.41 and 42.41 ± 10.48), although the improvement rates between two groups were not significantly different. Findings suggest that none of the cysteamine and TA mesotherapy treatments measured by both mMASI and Dermacatch® methods have substantial advantages over the other; however, complications are less in the cysteamine than the TA mesotherapy group.

Melasma is an acquired dysfunction of melanogenesis, that poses a major therapeutic challenge and tends to recur after therapy. Several combination therapies are being tested nowadays for the treatment of melasma, with promising results. Metformin, an anti-diabetic medication, seems to inhibit melanogenesis by different mechanisms. In addition, there has been a long-term improvement in melasma after microneedle therapy. To evaluate the potential therapeutic role of topical metformin combined with micro-needling for the treatment of melasma. Eighteen patients with melasma received treatment in split-face manner, right side with micro-needling and topical metformin, while the left side was treated with micro-needling and topical placebo for four sessions at 2-week intervals. Hemi-mMASI score was used for the final evaluation of results. The variability pattern in Hemi-mMASI score between both sides revealed significant reduction in the right side (micro-needling + metformin), as compared to the left side (micro-needling + placebo) (2.39 ± 1.42 vs 4.72 ± 1.27, p = 0.001). The effectiveness of topical metformin in the management of melasma could be significantly improved by pretreatment with micro-needling as a combined therapy, without any apparent side effects.

Introduction Melasma is a chronic refractory pigmentation disorder. Kligman triple (KT) formula is the gold standard. A dermocosmetic (DC) serum containing vitamin B3 and 2‐mercaptonicotinyl glycine has been developed for melasma. This study assessed the benefits of DC serum compared to KT in melasma. Material and Methods A randomized, single‐blind 6‐month study was conducted in women with melasma. Subjects were randomized to Group A (morning: serum; evening: cream, for 6 months) or to Group B (1st 3 months: morning: skin hydrating gel; evening: KT, followed by 3 months of DC routine regimen); all subjects applied a sunscreen with an SPF 50+ twice daily. Assessments included MASI, mMASI, IGA, skin hydration, radiance and fine wrinkles, tolerance, and quality of life (QoL) using MELASQOL. Results Ninety‐one women aged 44 ± 6 years of Phototypes III (30%) and IV (36%) were recruited. Both regimens significantly (p < 0.05) improved MASI after 3 months. A clinically relevant difference in favor of KT was observed. Three months after the switch, both Group A (38.1%) and Group B (41.2%) provided a similar significant (p < 0.05) percentage reduction of MASI score, with no between‐group difference. The mMASI and IGA showed similar results. QoL and skin hydration significantly (p < 0.05) improved in both groups after 6 months. Skin radiance and fine wrinkles also improved. Global tolerance was better with the DC routine. Conclusions Both DC routine and KT significantly improved melasma after 3 months of use. DC further improved melasma when replacing KT for 3 further months, with similar results when used alone for 6 months.

Background Melasma management remains challenging due to its multifactorial nature pathogenesis and recurrent nature. Previous studies showed positive effects of botulinum toxin A (BoNT‐A) for treating and preventing ultraviolet‐induced hyperpigmentation. Objective To evaluate the effectiveness of adjunctive incoBoNT‐A injection combined with triple combination cream (TCC, 4% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide) for treating and preventing melasma recurrence compared to topical therapy alone. Methods A split‐face study was conducted in 30 female patients with melasma. One side of the face was randomly applied TCC to the melasma‐affected areas for 12 weeks (monotherapy), while the contralateral side received TCC and intradermal incoBoNT‐A at baseline and week 12 (combination therapy side). Evaluations were performed at baseline and 2, 4, 8, 12, 16, 20, and 24 weeks. Clinical improvement and melanin index were assessed using the MASI score on the malar area (MASIm), and Colorimeter respectively. Patient satisfaction was also evaluated. Results Twenty‐eight subjects completed the study. The combination therapy side showed significant MASIm decrease at week 2 (p = 0.0032), while the monotherapy side showed no significant change. At 4 weeks, a greater reduction of MASIm was observed in the combination therapy side (MASIm 14.5 and 11.54, 20.41% reduction) when compared to the monotherapy side (MASIm 11.68 and 11.79, 0.93% worsening). At week 12, worsening of melasma was observed on both sides during the summer period. At week 24 (3 months after discontinuing TCC), MASIm was 14.79 on the monotherapy side (worsen 21.03% from baseline) and 9.14 on the combined technique (36.97% improvement, p = 0.0003). Patients' satisfaction was higher for the combination therapy when compared to the monotherapy at the end of the study (8.92 vs. 7.04, p < 0.0001). No serious adverse events occurred. Conclusion Intradermal incoBoNT‐A injection combined with TCC demonstrated superior efficacy in melasma treatment and recurrence prevention compared to TCC monotherapy.

Objective To investigate the efficacy and safety of broadband light (BBL) combined with intradermal injection of tranexamic acid for treating melasma. Methods 120 women with melasma admitted to our hospital from January 2021 to April 2022 were randomly categorized into the following groups: control group, treated with 250 mg tranexamic acid given orally twice daily, except during menstruation; group I, treated with BBL (Sciton, Inc., USA) monthly; group II, received intradermal injections of tranexamic acid monthly; and group III, treated with BBL with intradermal injection of tranexamic acid monthly. Treatment in each group lasted three months. The MASI (Melasma Area Severity Index) and VISIA (Canfield VISIA Complexion Analysis) were used for evaluation. Results After treatment course, MASI scores and VISIA brown spot and red zone ranking improved in all four groups (p < 0.05). The decrease in MASI scores and improvement rates of VISIA brown spot and red zone rankings were not significantly different among the control group, group I, and group II; however, the decreased MASI scores and improvement rates of VISIA brown spot and red zone rankings were significantly higher in group III than in the other three groups (p < 0.05). Conclusion The effect of BBL combined with the intradermal injection of TA in the treatment of melasma is remarkable. This combination therapy can be an alternative and effective treatment for managing melasma.

Background While the gold standard treatment for melasma is triple combination cream (TCC), arbutin and kojic acid demonstrate their benefits and may be used as an alternative. Aims To investigate the efficacy of cream containing alpha‐arbutin 5% and kojic acid 2% (AAK) compared with TCC for melasma treatment. Patients/Methods A split‐faced, randomized study was conducted among 30 participants with melasma, and all were randomized to receive AAK or TCC on each side of their face for 12‐week along with 4‐week follow‐up period. The melanin index (MI), modified Melasma Area Severity Index (mMASI), and physician global assessment (PGA) scores were used to measure the effectiveness of interventions. Recurrence of melasma after treatment discontinuation was evaluated by MI and mMASI. Patient satisfactions and adverse effects were also evaluated. In the analysis, the mean difference (MD) was used for MI and mMASI, while Wilcoxon signed‐rank test was for the PGA scores, adverse effects, and patient satisfaction. Results The MD of MI and mMASI scores were not different between groups (mMASI [p = 0.344] and MI [p = 0.268]). The PGA scores only showed improvement on the TCC‐treated side (p = 0.032). Compared to the AKK group, the subjects with TCC showed higher severity of recurrence (MI [p = 0.004] and mMASI [p = 0.045]). No difference in patient satisfaction score between the groups, but erythema and stinging were higher in the TCC group. Conclusions The AAK cream appeared to be effective for melasma treatment, highlighting a lower recurrent rate and fewer adverse events than standard therapy. Trial Registration: thaiclinicaltrials.org: TCTR20230124004

Background Melasma is a hyperpigmentary disorder causing cosmetic disfigurement. We aimed to compare the efficacy and safety of tranexamic acid (TXA) microinjections with TXA mesoneedling for facial melasma. Methods This randomized assessor‐blind split‐face controlled trial included patients with symmetric facial melasma. One side of the face received TXA (100 mg/ml) mesoneedling and the other side intradermal TXA microinjections. The interventions were repeated three times with 4‐week intervals (weeks 0, 4, and 8). The primary outcome was improvement in modified Melasma Area and Severity Index (mMASI) 4 weeks after the final treatment session. Secondary outcomes were complications and patient satisfaction with the treatments evaluated by a visual analog scale (VAS). Results All 27 patients included in the study were female (mean age: 44.22 ± 8.39 years). Both groups were comparable in terms of mMASI scores before and after treatment (standardized mean difference [SMD] = 0.32, 95% confidence interval [CI] −0.22; 0.85, p = 0.248 and SMD = −0.13, 95% CI −0.66; 0.40, p = 0.633, respectively). The mMASI score change from baseline was not different (SMD = −0.39, 95% CI −0.93; 0.15, p = 0.157). However, patient satisfaction was significantly higher with TXA mesoneedling (SMD = 0.77, 95% CI 0.21; 1.32, p = 0.007). Post‐inflammatory hyperpigmentation occurred in one patient in the TXA mesoneedling group. Erythema, scaling, and edema were significantly higher with TXA mesoneedling (p < 0.001). Conclusions TXA mesoneedling was comparable with TXA microinjection in the treatment of facial melasma, while patient satisfaction was significantly higher with TXA mesoneedling; however, the high frequency of complications occurring with this treatment should be taken into account.

Melasma is a common hyperpigmentary skin disorder. Because of its high prevalence and serious complications, including negative psychiatric effects, early diagnosis and treatment would be essential. This randomized, double-blind, case-controlled clinical trial compared the efficacy of niosomal tranexamic acid (TXA) 2%/niacinamide (NCA) 2% cream and conventional TXA 5%/NCA 4% cream with topical hydroquinone (HQ) 4% cream as a gold standard in melasma patients. A total of 99 patients were randomly assigned to three groups: Group A received niosomal TXA/NCA cream, Group B received conventional TXA/NCA cream, and Group C received HQ cream for three months. Each patient attended five dermatologist visits to evaluate clinical efficacy. All treatment groups showed a considerable reduction in melanin index and modified melasma area and severity index (mMASI) scores, as well as a notable improvement in patients’ quality of life. Although both niosomal TXA/NCA cream and conventional TXA/NCA cream were as effective as HQ cream in management of melasma, adverse reactions and relapse were observed in HQ group. Niosomal or conventional TXA/NCA creams are as effective as HQ 4% cream and due to less serious adverse reactions they would be better choices than HQ-containing preparations in hyperpigmentary disorders. Clinical Trial Registration No. : IRCT20220609055116N1 (Approval date: 07/23/2023).