Cysteamine Isobionic-Amide Complex Versus Kligman's Formula for the Treatment of Melasma: Equal Efficacy and Rapid Onset of Action.

BACKGROUND: Modified Kligman's formula (mKF) is the gold standard treatment for melasma; however, its prolonged use is not recommended due to side effects. Cysteamine is a potent, safe, and effective depigmenting agent. Here, we conducted a double-blind, randomized, and placebo-controlled clinical trial to assess the efficacy of cysteamine isobionic-amide -- a complex with enhanced depigmenting efficacy -- and compared it to mKF for the treatment of melasma. METHODS: This study involved a total of 80 patients divided into 3 groups: cysteamine-isobionic amide, placebo, or mKF. The modified Melasma Area Severity Index (mMASI) score and spectrophotometric evaluation were conducted at baseline, week 4, week 8, and week 16. Dermatological assessment, patients’ feedback, and satisfaction including quality-of-life scores were also collected. RESULTS: At week 4, cysteamine isobionic-amide and mKF groups showed an equivalent onset of action in terms of mMASI and skin pigmentation contrast reduction. The 2 groups significantly reduced melasma severity and improved the overall skin condition with a comparable efficacy at week 16. Quality of life of melasma patients was significantly improved in the cysteamine isobionic-amide group at week 8 and further at week 16 (P<0.001) compared to the mKF group. Patients’ feedback and satisfaction were higher with the cysteamine isobionic-amide product compared to mKF. CONCLUSION: Cysteamine isobionic-amide provided a rapid onset of action and was as effective as the mKF for the treatment of melasma. The data suggest that cysteamine isobionic-amide could potentially be an acceptable alternative to mKF for the long-term treatment of melasma. J Drugs Dermatol. 2024;23(2):9-16.  doi:10.36849/JDD.7428.

Comparative effectiveness and safety of topical methimazole 5% monotherapy versus combination of Q-Switched Nd: YAG Laser and topical methimazole 5% in patients with refractory melasma.

INTRODUCTION: Melasma is an acquired pigmentary disorder which currently has no definitive treatment. Although topical drugs containing hydroquinone are the basis of treatments, they are usually associated with recurrence. We aimed to evaluate the effectiveness and safety of monotherapy with topical methimazole 5% versus combination of Q-Switched Nd: YAG Laser and topical methimazole 5% in patients with refractory melasma. METHODS: A total of 27 women with refractory melasma were included. We applied topical methimazole 5% (once a day) with three passes of QSNd: YAG laser (Wavelength: 1064 nm, pulse energy: 750 mJ, fluence: 1.50  J/cm2 , spot size: 4 × 4 mm, hand piece: fractional, JEISYS company) for six sessions on the right half of the face, and topical methimazole 5% (once a day) on the left half of the face, for each patient. The treatment course was 12 weeks. Evaluation of effectiveness was done with the Physician Global Assessment (PGA), Patient Global Assessment (PtGA), Physician satisfaction (PS), Patients satisfaction (PtS), and mMASI score. RESULTS: PGA, PtGA, and PtS were not significantly different between the two groups at any time (p > 0.05). PS in the laser plus methimazole group was significantly better than methimazole group at 4th, 8th, and 12th weeks (p < 0.05). The rate of PGA improvement in the combination group was significantly better than the monotherapy over time (p < 0.001). The changes of mMASI score between the two groups did not significantly differ at any time (p > 0.05). There was no significant difference in the adverse events between the two groups. CONCLUSION: Combination therapy with topical methimazole 5% and QSNY laser can be considered as an effective way to treat refractory melasma.

Pigmentation control in pregnancy-induced melasma: Clinical assessment of a non-hydroquinone, non-retinol pigment-correcting serum.

BACKGROUND: Melasma is an acquired disorder that results in irregular brown patches on the skin that can occur due to hormonal changes. Although pregnancy-induced melasma is usually temporary, it can become a chronic condition, with significant negative impact on quality of life (QoL). AIMS: Determine the efficacy and tolerability of a topical, non-hydroquinone, non-retinol pigment-correcting serum (LYT2) for the treatment of pregnancy-induced melasma. METHODS: This 12-week, single-center clinical trial enrolled 34 non-pregnant women who developed mild to severe facial melasma following a previous pregnancy (mean age, 42 years). LYT2 was applied twice daily to facial skin for 12 weeks in addition to a basic skincare regimen. Outcomes included changes from baseline in skin physiology parameters, such as brightness (L*), using objective digital image analysis, investigator-rated Overall Hyperpigmentation scale, Global Improvement, and Melasma Area and Severity Index (MASI), as well as subject-assessed Melasma Quality of Life Scale. Subjects also completed a questionnaire on self-perceived efficacy and attributes of the study product. Tolerability was assessed by the investigators (erythema, scaling, and edema) and subjects (burning/stinging and itching). Clinical assessments were conducted at baseline and Weeks 4, 8, and 12. RESULTS: LYT2 provided statistically significant reductions in overall hyperpigmentation scores as early as Week 4 (-5.8% change from baseline) and continued through Week 12 (-14.6% change from baseline; all p < 0.001). Significant improvements in MASI scores and QoL were also achieved following LYT2 treatment, which was well tolerated. CONCLUSIONS: LYT2 represents a new efficacious alternative to hydroquinone-based treatments for pregnancy-induced melasma.

Comparison of the efficacy of cysteamine 5% cream and hydroquinone 4%/ascorbic acid 3% combination cream in the treatment of epidermal melasma.

BACKGROUND: Few safe and effective treatments are available for melasma. Cysteamine, a non-melanocytotoxic molecule is a safer alternative to hydroquinone and usable for long-term use. AIM: To evaluate the effect of cysteamine 5% cream in the treatment of melasma. METHODS: Sixty-five of 80 patients completed this single-blind, randomized, controlled trial. The patients received cysteamine 5% or hydroquinone 4%/ascorbic acid 3% (HC) cream. The therapeutic response was evaluated by modified MASI (mMASI) and melanin index (SkinColorCatch) after 2 and 4 months of treatment. The effect of treatment on the quality of life was also assessed. RESULTS: The decrease in mMASI score was from 6.69 ± 2.96 to 4.47 ± 2.16 in the cysteamine group and from 6.26 ± 3.25 to 3.87 ± 2.00 in the HC group after 4 months (p values < 0.001). The melanin index decreased from 37.72 ± 10.17 to 31.47 ± 11.90 in the cysteamine group and from 36.37 ± 10.80 to 23.16 ± 8.83 in the HC group after 4 months (p-value = 0.003 and <0.001, respectively). The difference between mMASI score at baseline and month 4 was not significant between both groups (p-value > 0.05). The difference between the melanin index at baseline and month 4 was significantly more pronounced in the HC group (p-value = 0.002). Quality of life improved in both groups (p-value < 0.05), but was not significantly different between groups (p-value > 0.05). CONCLUSION: Cysteamine was confirmed to be an effective treatment for melasma, with equivalent results to HC in reducing mMASI score and improving quality of life, despite lesser melanin index reduction observed. Cysteamine and HC efficacy was confirmed in patients recalcitrant to previous treatments, by a significant reduction of mMASI and melanin index.

A comparative evaluation of the efficacy of intralesional tranexamic acid versus platelet rich plasma in the treatment of melasma.

Melasma is a benign, acquired disorder of hyperpigmentation commonly affecting the face. Though easily diagnosable, a tangible treatment for melasma still remains elusive. Our aim was to compare the therapeutic efficacy and safety of tranexamic acid (TXA) and platelet rich plasma (PRP) microinjections in treating patients with melasma. In total, 40 patients with melasma (10 males, 30 females; age range: 21-54 years) were enrolled, and randomly assigned to one of the two groups consisting of 20 patients each. Group A (3 males, 17 females) received intradermal microinjections of TXA (4 mg/ml) and group B (5 males, 15 females) received intradermal microinjections of PRP, once every 4 weeks for a total of five treatment sessions. Clinical images were taken at each visit and improvement in melasma was evaluated using both melasma area severity index (MASI) and modified melasma area severity index (mMASI) scoring systems. Percentage reduction of both MASI and mMASI scores were also assessed at each visit, and the grade of melasma improvement was accordingly outlined for each patient. The study was completed by 18 patients in group A (TXA) and 15 patients in group B (PRP). In group A, both MASI and mMASI scores reduced significantly from 16.6 ± 9.227 at baseline to 10.028 ± 8.07 at end point; and 8.885 ± 5.418 at baseline to 4.639 ± 3.863 at end point, respectively (p value <0.01). Similarly in group B significant reduction in both scores were observed at the end of treatment. MASI declined from 20.42 ± 7.979 to 12.253 ± 7.37; and mMASI plummeted to 5.613 ± 3.98 from 10.673 ± 4.642 (p value <0.01). In group A, the difference in mean reduction of MASI and mMASI from baseline to end point was 6.572 ± 4.528 and 4.211 ± 2.647, respectively. In group B, the difference in mean reduction of both scores at the end of treatment reflected values of 8.167 ± 4.975(MASI) and 5.06 ± 2.977 (mMASI). No significant adverse effects were encountered in both treatment arms during the entire duration of study. Both TXA and PRP microinjections were found to be effective and safe therapeutic options for melasma, providing rapid and substantial improvement even when used as standalone therapies. Although PRP mesotherapy was found to be slightly better than intradermal TXA in our study, the results were not significant statistically.

Topical Stabilized Cysteamine as a New Treatment for Hyperpigmentation Disorders: Melasma, Post-Inflammatory Hyperpigmentation, and Lentigines.

Cysteamine is an aminothiol naturally present in cells of the human body as an antioxidant resulting from the degradation of Coenzyme A. Physiologically it is well distributed in mammalian tissues. Highly concentrated in human milk, cysteamine acts as an intrinsic antioxidant and is known for its protective role. Multiple studies now document that cysteamine is a potent skin depigmenting agent. Historically, its rapid oxidation and very offensive odor made it difficult for topical use until recently when stabilization of cysteamine was achieved. This has led to an acceptable galenical form for topical application. Since 2015, the efficacy, safety, and tolerability of stabilized cysteamine (st.Cys) has been demonstrated in multiple clinical studies, as well a case reports. Stabilized cysteamine has demonstrated significant effectiveness for the treatment of melasma by two double-blind randomized and vehicle control trials. Stabilized cysteamine (st.Cys) has shown to be as effective as well-known depigmenting therapies, including triple combination cream or tranexamic acid mesotherapy, with higher tolerability. A recent clinical trial has shown considerable efficacy of topical cysteamine for the treatment of senile lentigines, which are usually considered to be resistant to topical depigmenting agents. Topical stabilized cysteamine can be regarded to as one of the most potent treatments available for hyperpigmentation disorders in humans. J Drugs Dermatol. 2021;20(12): 1276-1279. doi:10.36849/JDD.6367.

Caracterización clínico-epidemiológica de pacientes con daño actínico crónico. Cochabamba, Bolivia / Clinical-epidemiological characterization of patients with chronic actinic damage. Cochabamba, Bolivia

RESUMEN Introducción: el daño actínico crónico es un grupo de alteraciones en la estructura, función y apariencia de la piel como resultado de la exposición no controlada a las radiaciones ultravioletas. Puede provocar el cáncer de piel. Objetivo: caracterizar a los pacientes con daño actínico crónico, atendidos en la consulta de Dermatología del Hospital Comunitario Valle Hermoso, en el departamento de Cochabamba, Bolivia. Materiales y métodos: se realizó un estudio clínico descriptivo, prospectivo, en un universo de 1 833 pacientes diagnosticados con daño actínico crónico, atendidos en la consulta de Dermatología del Hospital Comunitario Valle Hermoso, en Cochabamba, entre septiembre de 2017 y septiembre de 2018. Se evaluaron las variables edad, sexo, color y fototipo de piel, ocupación, uso de medios de protección solar, exposición a otro tipo de radiaciones, manifestaciones clínicas de fotodaño y altitud del lugar de residencia. Resultados: predominaron el grupo de edad de 25 a 59 años, el sexo femenino, el color de piel mestizo (77,08 %), el fototipo de piel IV (76,98 %) y la ocupación comerciante (72,56 %). La mayoría de los pacientes (82,7 %) no utilizaron medios de protección solar, y el 99,8 % no tuvieron exposición a otro tipo de radiaciones. Las lesiones por fotodaño que prevalecieron fueron melasma (83,03 %) y lentigos (12,22 %). El 99,29 % vivían en zonas de gran altitud. Conclusiones: se caracterizaron los pacientes con daño actínico crónico, obteniendo en algunas variables estudiadas resultados similares a los mencionados por otros investigadores (AU).

ABSTRACT Introduction: chronic actinic damage is a group of alterations in the structure, function, and appearance of the skin as a result of uncontrolled exposure to ultraviolet radiation. It can cause skin cancer. Objective: to characterize the patients with chronic actinic damage, treated at the Dermatology consultation of Valle Hermoso Community Hospital, in the department of Cochabamba, Bolivia. Materials and methods: a descriptive, prospective clinical study was conducted in a universe of 1,833 patients diagnosed with chronic actinic damage, treated at the Dermatology clinic of the Valle Hermoso Community Hospital, Cochabamba, between September 2017 and September 2018. The variables age, sex, skin color, skin phototype, occupation, use of sun protectors, exposure to other types of radiation, clinical manifestations of photodamage and altitude of the place of residence were evaluated. Results: the age group from 25 to 59 years, the female sex, mestizo skin color (77.08 %), the IV skin phototype (76.98 %) and merchant occupation (72.56 %) predominated. Most patients (82.7 %) did not use sun protection means, and 99.8 % had no other radiation exposure. The prevailing photodamage lesions were melasma (83.03 %) and lentigo (12.22 %). 99.29 % lived in high altitude areas. Conclusions: the patients with chronic actinic damage were characterized, obtaining in some variables studied results similar to those mentioned by other researchers (AU).

Feasibility of oral tranexamic acid for vitiligo patients with melasma.

Melasma and vitiligo are both common pigmentary disorders, and the treatment is challenging. Oral tranexamic acid (TA) is effective for refractory melasma; however, the feasibility of TA in vitiligo patients with melasma was not studied. To evaluate the treatment outcomes and adverse effects of oral TA in vitiligo patients with melasma. We conducted a retrospective analysis of vitiligo patients who received oral TA for melasma in a tertiary dermatologic center from January 2017 to August 2020. We enrolled 32 patients with concomitant vitiligo and melasma on the face. The mean duration of the improvement of melasma that patients reported is around 1.64 months of treatment. The first sign of repigmentation of the vitiligo lesions occurred at 1 month of treatment. 84.38% of the patients achieved a mild to good degree of improvement of melasma (0%-75% improvement), whereas 81.25% of the patients achieved a moderate to excellent degree of improvement of vitiligo (25%-100% improvement) via physician global assessments. No significant adverse event was noted. No patients experience vitiligo disease deterioration during TA treatment. Oral TA may be a feasible option for melasma in vitiligo patients.

Study of autologous platelet-rich-plasma versus its combination with intense pulsed light in treatment of melasma.

Melasma is a common acquired hypermelanosis of variably successful therapies with frequent relapse. Platelet-rich-plasma (PRP) is a promising treatment in melasma, alone or combined with other treatments. We evaluated efficacy of autologous PRP in melasma treatment and the effect of combined intense pulsed light (IPL). Study included 20 Egyptian female melasma patients. PRP was injected in all melasma area and IPL was used on the right hemi-face. Melasma Area and Scoring Index (MASI) of melasma area, modified-MASI (mMASI) of PRP-IPL side and of PRP side significantly decreased after treatments (p-value < 0.05). There was no statistically significant difference between both sides regarding mMASI score or patient and physician satisfaction (p-value > 0.05). Our study provides the first comparison between PRP versus its combination with IPL in melasma treatment. We think the improvement of melasma with regression of melasma scores after PRP treatment is an important finding.

Clinical Characteristics of UM and Association of Metastasis of Uveal Melanoma with Congenital Oculocutaneous Melanosis in Asian Patients: Analysis of 1151 Consecutive Eyes.

PURPOSE: To analyze the clinical characteristics of uveal melanoma (UM) and evaluate the relationship of congenital oculocutaneous melanosis (OCM) to the prognosis of Asian patients with UM. DESIGN: Retrospective cohort study. PARTICIPANTS: We included a total of 1151 Asian patients with UM who were managed at the Beijing Tongren Hospital from June 26, 2005, to July 27, 2020. METHODS: I-125 plaque brachytherapy, local resection, thermotherapy, or enucleation. MAIN OUTCOME MEASURES: Melanoma-related metastasis and death. RESULTS: Of 1151 Asian patients with UM, congenital OCM was present in 23 (0.20%). The melanocytosis involved the conjunctiva (78%), sclera (74%), eyelid (70%), face (26%), forehead (2.2%), iris (0.87%), choroid (0.87%), and auricle (0.4%). Univariate analysis of Cox proportional hazards regression model showed that age, tumor thickness, largest tumor basal diameter, and ciliary body involvement were the risk factors for the poor prognosis of Asian patients with UM. By multivariable analysis, the only factor predictive of melanoma-related metastasis and death was the largest tumor basal diameter (hazard ratio [HR], 1.21 [1.11-1.33], P < .001; 1.17 [1.01-1.35], P = 0.033). Probability-of-censoring weighted (IPW) estimation was used to mitigate selection bias due to loss to follow-up. Probability-of-censoring weighted estimation revealed the largest tumor basal diameter and ciliary body involvement were associated with metastasis (HR, 1.29 [1.15-1.45], P < 0.001; HR, 2.64 [1.01-6.90], P < 0.048). During the median follow-up period of 53 (33-67) months, 2 patients with OCM (8.7%) developed melanoma-related metastasis. By using nested case-control design and matched with the factors of age, largest tumor basal diameter, tumor thickness, and ciliary body involvement, Kaplan-Meier survival analysis showed that UM combined with OCM did not increase the risk of melanoma-related metastasis and death (P = 0.68, log-rank test). CONCLUSIONS: The prominent risk for metastasis from UM was the largest tumor basal diameter in Asian patients. Estimation of IPW revealed that the largest tumor basal diameter and ciliary body involvement were the risk factors for UM metastasis. Patients with UM combined with OCM had a similar risk for metastasis compared with those with no OCM.

The use of retinoic acid in association with microneedling in the treatment of epidermal melasma: efficacy and oxidative stress parameters.

This study aimed to evaluate the effectiveness of isolated treatment with retinoic acid and its combination with the microneedling technique in facial melasma, seeking to associate these results with possible oxidative damage. This is a blinded randomized clinical trial with 42 women with facial melasma (skin phototype I-IV), randomized into Group A (microneedling and 5% retinoic acid) or Group B (5% retinoic acid alone). Four procedures were applied with 15 days intervals (4 blood collections). Clinical improvement was assessed using the Melasma Area Severity Index (MASI). Serum oxidative stress levels were evaluated by protein oxidation (carbonyl), lipid peroxidation (TBARS) and sulfhydryl groups, as well as enzyme activities of superoxide dismutase (SOD) and catalase (CAT). The statistical analyzes were performed by generalized estimation equation (GEE). There was a reduction in MASI scale and TBARS levels in both groups over time (p < 0.05), with no difference between groups (p = 0.416). There was also a substantial increase in the carbonyl levels at 30 days (p = 0.002). The SOD activity decreased after 30 days, regardless of group (p < 0.001), which was maintained after 60 days. In Group A, there was a reduction in sulfhydryl levels at 60 days (p < 0.001). It is important to highlight that both groups demonstrated efficacy in the clinical improvement of melasma within at least 60 days, reducing the MASI score by almost 50%. However, microneedling with retinoic acid seems to be the worst treatment because there is a reduction in the non-enzymatic antioxidant defense, which is important to protect against oxidative stress.

Clinical evaluation of efficacy and tolerability of cysteamine 5% cream in comparison with tranexamic acid mesotherapy in subjects with melasma: a single-blind, randomized clinical trial study.

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.

The Vascular Component of Melasma: A Systematic Review of Laboratory, Diagnostic, and Therapeutic Evidence.

BACKGROUND: Melasma is a common acquired disorder of hyperpigmentation, classically manifesting as symmetric brown patches on the face. Although the exact pathogenesis is not fully understood, vascular abnormalities have been implicated in melasma. OBJECTIVE: To evaluate the laboratory and clinical evidence regarding the safety and efficacy of antivascular agents for the treatment of melasma. METHODS: A systematic review of PubMed, EMBASE, and Cochrane was conducted on May 13, 2020, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Original research articles investigating the role of vascularity and/or evaluating the use of antivascular therapeutics in melasma were included. Clinical recommendations were based on the American College of Physicians guidelines. RESULTS: A total of 34 original research articles as follows were identified: 4 laboratory studies, 15 diagnostic studies, and 15 therapeutic studies. CONCLUSION: There is promising evidence supporting the use of tranexamic acid and laser/light therapies to treat the vascular component of melasma, and more rigorous clinical trials are needed to validate their efficacy. Clinicians may consider treatment with one or more antivascular therapeutics in patients with melasma. Further research is warranted to characterize the role of cutaneous vascularization in melasma and may provide insights for novel therapies.

Treatment of Refractory Melasma in Asians With the Picosecond Alexandrite Laser.

BACKGROUND/OBJECTIVES: The picosecond Alexandrite laser was studied in our practice with the diffractive lens array and the flat optic to treat melasma. METHODS AND MATERIALS: Sixty patients with melasma were treated in a prospective investigation with the picosecond Alexandrite laser. Nineteen patients were treated with the flat optic and 41 patients were treated with the diffractive lens array. Treatments were performed with 1 pass at 2-week intervals for 6 treatments. The Melasma Severity Index (MSI) was used to evaluate the patients before treatment and 3 and 6 months after the final treatment session. RESULTS: At 6 months after the last treatment, there was an 18.5% difference between the groups with a 75.7% improvement in the MSI in patients with the diffractive lens array and a 57.2% improvement in the MSI score in patients with the flat optic. At 6 months, there was recurrence of melasma in 5% of the cases with no hyperpigmentation with the diffractive optic in contrast to recurrence in 16% of the cases in the flat optic group and a transient macular hyperpigmentation in 21% of the cases. CONCLUSION: This investigation highlights the utility of a picosecond Alexandrite laser with a flat and diffractive lens to successfully treat a large percentage of Asian patients in a sunny climate.

Clinical Efficacy of Topical Tranexamic Acid With Microneedling in Melasma.

BACKGROUND: Melasma is a common, recurrent, and refractory cause of facial pigmentation resulting in cosmetic disfigurement. Tranexamic acid (TA) has been used systemically and locally for clearance of pigmentation. OBJECTIVE: To assess the clinical efficacy of topical TA (10%) with microneedling in melasma. METHODS: A split face, prospective, randomized, open-label study with a sample size of 40. Left or right side of the face was chosen randomly and microneedling was done on both the sides, followed by 10% TA solution application on one side of the face (test side) and distilled water on the other side of face (control). The procedure was done at 2 weekly intervals (0, 2, 4, and 6 weeks). Clinical images were taken at each visit including modified Melasma Area and Severity Index (mMASI) scoring of each half of the face to assess the clinical response along with patient satisfaction scores and side effects. RESULTS: On the test side, there was 65.92% improvement in the mean mMASI score compared with 20.75% on the control side of the face at the end of 8 weeks. CONCLUSION: Tranexamic acid may be a promising therapeutic agent in melasma and the topical solution along with microneedling seems to be efficacious.

Tranexamic Acid for Melasma Treatment: A Split-Face Study.

BACKGROUND: Melasma is an acquired hyperpigmented skin disorder. Tranexamic acid (TXA) prevents ultraviolet radiation induced pigmentation in melasma through interfering with the plasminogen-plasmin pathway. OBJECTIVE: This study was conducted to evaluate the therapeutic effect and safety of TXA by intradermal injection versus TXA with microneedling for melasma treatment. METHODS: Fifty-six female patients with bilateral symmetrical melasma were recruited in a split-face study. All patients received an intradermal injection of TXA on one side of the face, and the other side received TXA with microneedling for 6 sessions at 2 weeks intervals. Clinical efficacy was assessed using a modified Melasma Area Severity Index (mMASI) score at the baseline and after treatment. Global photographs underwent blinded review by 2 dermatologists. Patient self-assessment and satisfaction were recorded. RESULTS: After the treatment, the mMASI score was significantly reduced compared with the baseline in both treated sides (p < .001). No significant difference between both treated sides (p > .05). Patient satisfaction was higher in the microneedling-treated side than the intradermal-injected side (p < .001). No significant adverse effects were observed in both treated sides. CONCLUSION: Intradermal injection and microneedling of TXA could be safe and effective in melasma treatment. Microneedling of TXA was significantly more satisfying to the patients.

Study of efficacy of microneedling and mesoneedling in the treatment of epidermal melasma: A pilot trial.

BACKGROUND: Melasma is a difficult to treat pigmentation disorder. However, some successes have been attained by microneedling. The aim of the present study was to evaluate the efficacy of microneedling using meso-depigmentation solution (mesoneedling) in comparison with standard microneedling, over a 4-month treatment period. METHODS: As a part of this pilot study, 20 patients received microneedling on one side and mesoneedling on another side of their face. Treatment was repeated on a monthly basis for 4 months. Treatment efficacy was defined through Dermacatch® colorimetry, modified Melasma Area and Severity (mMASI) score determination, Investigator's Global Assessment (IGA), and patient questionnaires, whereby all assessments were conducted at the baseline, as well after 2 and 4 months of treatment. RESULTS: Before treatments, mean difference between pigmented and normal skin calculated by Dermacatch® was 43.7 ± 20.12 and 44.6 ± 20.72 in microneedling sides and mesoneedling sides, respectively. After two and four sessions, these values declined to 34.5 ± 16.26 and 28.05 ± 13.79 on the side subjected to microneedling, while 29.75 ± 15.07 and 20.45 ± 10.58 were measured on the mesoneedling side. Statistically significant differences have been observed between microneedling and mesoneedling treatments at both time points (P = .0001, P = .0001). The mMASI scores obtained upon treatment completion were significantly lower on both the microneedling and the mesoneedling side. The IGA and patients' self-assessment scores further confirmed that both treatments were effective in treating melasma, without producing any notable side-effects or complications. CONCLUSION: In sum, both microneedling and mesoneedling are effective in decreasing melanin content in the epidermal melasma lesions.

Comparing the efficacy of Myjet-assisted tranexamic acid and vitamin C in treating melasma: A split-face controlled trial.

BACKGROUND: Melasma is a benign and chronic hypermelanosis characterized by irregular light brown to dark brown patches of hyperpigmentation on the skin. Oral tranexamic acid (TA) or vitamin C (VC) supplementation has been one treatment choice. TA interferes with keratinocyte-melanocyte interactions, and VC functions by reducing melanin production resulting in skin rejuvenation and whitening. AIM: The aim of the present study was to compare the efficacy and safety of Myjet assisted transdermal injection of TA vs VC in the treatment of melasma. METHODS: In this split-face controlled trial, 17 patients were randomized to receive eight weekly transdermal injections of TA or VC via Myjet either on the right or the left side of their face. MASI was measured from each side of the face at the baseline, at the middle, and at the end of treatment. RESULTS: A reduction in MASI was observed for TA and VC separately (P value < 0.05). The difference in efficacy between TA and VC group was not statistically significant (P value 0.05). Both treatments were well tolerated, with no serious adverse events reported. CONCLUSION: Weekly TA or VC transdermal injections can be an effective treatment for melasma. Further studies are required to validate these findings.

Platelet-rich plasma treatment for melasma: A pilot study.

BACKGROUND: Melasma treatments have varying success and are associated with some complications. AIMS: To assess the effectiveness of platelet-rich plasma (PRP) treatment for melasma. METHODS: Ten female patients with bilateral mixed-type melasma were enrolled in our randomized, split-face, single-blinded prospective trial. Over 4 treatment sessions that each took place every 2 weeks, PRP was injected intradermally on one side of the face (PRP condition) and normal saline on the other (control condition). PRP was prepared by using the YCELLBIO Kit® . Outcomes were evaluated with the modified Melasma Area and Severity Index (mMASI), Mexameter® , and Antera® 3D. Patient satisfaction was also assessed at baseline, at 2, 4, and 6 weeks, and 1 month after treatment completion. RESULTS: mMASI score and Antera® 3D-assessed melanin levels show significant improvement in the PRP condition than control condition between baseline and week 6, while patient satisfaction significantly increased over time. However, Mexameter® -assessed erythema and melanin indices did not significantly differ between the control and PRP conditions, though there was a trend toward reduced pigmentation in the latter. Finally, side effects of treatment were mild and resolved spontaneously within a few days. CONCLUSION: This is the first randomized, placebo-controlled trial study using PRP for treatment of melasma. PRP injection significantly improved melasma within 6 weeks of treatment in terms of mMASI scores, patient satisfaction, and Antera® -assessed melanin levels. Hence, intradermal PRP injection could be used as an alternative or adjuvant therapy for melasma. However, additional trials are needed for more rigorous evaluation of its long-term efficacy and safety.

A cream of herbal mixture to improve melasma.

BACKGROUND: Melasma is an acquired, common hyperpigmented disorder on the face. While many therapeutic approaches are available, their efficacy is moderate. OBJECTIVE: To investigate the safety and efficacy of a cream containing herbal mixture for melasma. METHODS: A total of 90 volunteers with melasma were enrolled in this randomized, double-blind, controlled clinical study, and they were randomly divided into three groups (A, B, and C). Patients in group A were treated with a cream containing herbal mixture, while groups B and C were treated with arbutin cream and placebo, respectively, twice daily for 12 weeks. Melasma area and severity index (MASI) score, melanin index (MI), erythema index (EI), changes in density of inflammatory cells, and adverse events were evaluated every 4 weeks. RESULTS: Although MASI scores declined significantly in both groups A and B (P < 0.05), a greater reduction was seen in group A (13.00-9.82 = 3.18 for group A; 12.65-10.84 = 1.81 for group B). Moreover, the cream containing herbal mixture, but not arbutin cream and placebo, significantly reduced EI and density of inflammatory cells after 12-week treatment (P < 0.05). No adverse reactions were observed in either group A or group C. In group B, two subjects experienced mild erythema and itching, which disappeared after stop using the arbutin cream. CONCLUSION: The cream containing herbal mixture is safe and effective for melasma.