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.

Roller Microneedle Combined with Tranexamic Acid Solution in Treating Melasma.

Melasma, a common, acquired facial pigmentation skin disorder, presents a straightforward clinical diagnosis but poses challenges in terms of effective management. The precise underlying causes of melasma remain elusive, and the current therapeutic approaches predominantly encompass pharmaceutical and laser interventions, with limited efficacy. Transdermal administration stands as a prevalent treatment method for melasma, often facilitated by the application of microneedles. Among these, tranexamic acid emerges as a frequently employed therapeutic agent. A subset of microneedles, known as roller microneedles, plays a significant role in this approach by delicately puncturing the epidermis with multiple fine needles, synergizing with drug delivery. This methodology not only enhances drug absorption but also augments treatment efficacy while minimizing tissue trauma. These attributes forecast promising avenues for the treatment of melasma. This article primarily introduces the combination of roller microneedle and tranexamic acid solution in the treatment of melasma and demonstrates the efficacy of roller microneedle and tranexamic acid solution in the treatment of melasma through clinical cases.

Extension Phase of a Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia.

BACKGROUND: Dyschromia can be associated with increased production and/or reduced clearance of pigmentation in the skin. Multiple pathways are involved in causality. A novel topical product was recently developed, which contains actives that have been validated through in-vitro and clinical studies to counteract pigmentation related to photodamage, PIH, and melasma. This study further evaluates the safety and efficacy of this product for facial dyschromia during an additional 3-month extension period following the completion of the previous 12-week multi-center trial.  Study Design: Subjects from the previous multi-center trial with mild to severe facial dyschromia at baseline were eligible to participate in this 3-month extension study upon completion of that trial. This extension study evaluated the continued use of the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) over a 3-month period. Subjects who were previously randomized to the novel topical product continued using it and for those previously randomized to hydroquinone 4% discontinued its use. Both cohorts continued daily sunscreen use. Blinded investigators assessed subjects at follow-up visits at 16, 20, and 24 weeks. RESULTS: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort.  Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement. J Drugs Dermatol. 2024;23(1):1266-1270.     doi:10.36849/JDD.7622.

Melanoma of the central nervous system based on neurocutaneous melanocytosis in childhood: A rare but fatal condition.

BACKGROUND: Melanomas of the central nervous system (CNS) based on neurocutaneous melanocytosis (NCM) are exceptionally rare in childhood and have been described only sporadically. Rapidly progressive disease may represent a major challenge for treating physicians, especially given the limited knowledge about this condition. This analysis aimed to increase knowledge about the occurrence and treatment of these malignancies. PROCEDURE: Data on diagnosis, treatment, and outcome of patients aged 0-18 years with CNS melanoma based on NCM recorded in the German Registry for Rare Pediatric Tumors (STEP registry) were analyzed. Additionally, published case reports on this condition were analyzed. RESULTS: In STEP, five patients with leptomeningeal melanoma based on NCM were identified, with a median age at melanoma diagnosis of 3.7 years. Various multimodal treatments were performed: (partial) resection (n = 4), irradiation (n = 2), trametinib (n = 3), different cytostatics (n = 2), and anti-GD2 immunotherapy (n = 1). All patients died between 0.3 and 0.8 years after diagnosis. Including published case reports, 27 patients were identified with a median age of 2.8 years at melanoma diagnosis (range: 0.2-16.6). Fourteen of 16 cases with reported data had a NRAS alteration (88%), particularly NRAS p.Q61K (85%). In the expanded cohort, no patient survived longer than 1 year after diagnosis despite multimodal therapy (including trametinib; n = 9), with a median survival of 0.4 years (range 0.1-0.9). CONCLUSIONS: CNS melanomas based on NCM in childhood are aggressive malignancies without curative treatment to date. Therapeutic approaches must be individualized. Genetic tumor sequencing is essential to improve understanding of tumorigenesis and potentially identify new therapeutic targets.

Comparing the Efficacy and Tolerability of Moderate to Severe Hyperpigmentation and Skin Unevenness.

Dyschromia is the result of irregular facial pigmentation. These cutaneous manifestations can have a significant impact on the quality of life of those affected, especially among females and skin of color. In this randomized, double-blinded, two-cell, single-center, 16-week clinical study, all subjects had moderate to severe (scores 4-9 on the modified Griffiths Scale) hyperpigmentation and skin unevenness of the face such that approximately 20% of subjects had post-inflammatory hyperpigmentation (PIH), 40% had overall mottled hyperpigmentation, and 40% had superficial melasma (Superficial Melasma was determined by Wood's Lamp Assessment). Study participants received either Product A (proprietary new formulation - Cysteamine HSA) or Product B (current marketed product - Cyspera®) and used the test product either in the morning or at night, beginning with every other day application, and then advanced to every day, or as tolerated. The results revealed that both Product A (Cysteamine HSA) and Product B (Cyspera®) had statistically significant improvement in facial hyperpigmentation and skin unevenness, however, Product A (Cysteamine HSA) had better tolerability results for scaling, peeling, burning, stinging, erythema, and dryness, indicating that Product A (Cysteamine HSA) outperformed Product B (Cyspera®). J Drugs Dermatol. 2024;23(1):1260-1265.     doi:10.36849/JDD.7584.

The efficacy and safety of microneedling with topical tranexamic acid for melasma treatment: A systematic review and meta-analysis.

OBJECTIVE: Microneedling with topical tranexamic acid (TXA) is a novel treatment option for melasma; however, the efficacy and safety of this combined administration therapy is in controversial. This study is conducted to address this issue of this technique in melasma. METHODS: An extensive literature review was performed to identify relevant trials, including randomized split-face studies, randomized controlled trials and prospective non-randomized split-face studies, comparing microneedling plus topical TXA to routine treatments or placebo. The primary outcomes were changes of the Melasma Area Severity Index (MASI)/modified MASI (mMASI)/hemi MASI between before and after treatment, as well as the changes between a particular treatment and microneedling plus TXA. The mean differences (MDs) and 95% confidence intervals (CIs) were calculated for the reduction of melasma severity scores from baseline to each time point. In contrast, the standard mean differences (SMDs) and 95% CIs were calculated for the differences in reduction in melasma severity scores between the experimental and control groups at each time point. RESULTS: A total of 16 trials were included in the systematic review and data synthesis. The pooled analysis demonstrated that MASI, mMASI, and hemiMASI scores decreased significantly at 4 weeks (MD = 1.85; 95% CI = 1.15-2.54), 8 weeks (MD = 3.28; 95% CI = 2.31-4.24), 12 weeks (MD = 4.73; 95% CI = 2.79-6.50), 16 weeks (MD = 3.18; 95% CI = 1.50-4.85), and 20 weeks (MD = 3.20; 95% CI = 1.95-4.46) after treatment when compared with baseline. The reduction in melasma severity scores of microneedling with TXA group at 4 weeks was more significant than the routine treatment group (SMD = 0.97; 95% CI = 0.09-1.86), while insignificant at 8 weeks (SMD = 1.21; 95% CI = -0.17 to 2.59), 12 weeks (SMD = 0.63; 95% CI = -0.03 to 1.29), 16 weeks (SMD = 0.61; 95% CI = -2.85 to 4.07), or 20 weeks (SMD = 1.04; 95% CI = -1.28 to 3.36). CONCLUSION: Despite the high heterogeneity across these studies, the current findings indicated that microneedling with topical TXA is an alternative treatment option for melasma treatment; and more well-designed studies are needed to confirm it.

Preparation of paeoniflorin-glycyrrhizic acid complex transethosome gel and its preventive and therapeutic effects on melasma.

Paeoniflorin (PF) and glycyrrhizic acid (GL) have skin beautifying effects of anti-inflammation, anti-oxidation, inhibition of melanin formation, and reduction of skin pigmentation. To improve the transdermal permeability of PF and GL in transdermal drug delivery system (TDDS) and enhance their anti-melasma efficacy, PF-GL transethosome (PF-GL-TE) was prepared by ethanol injection method, and finally gelled with carbomer-940 to form PF-GL-TE gel. Consequently, the obtained PF-GL-TE is small and uniform, with an average particle size and a PDI value of about 167.9 nm and 0.102. PF-GL-TE gel showed sustained release behavior and high transdermal permeability in vitro release and transdermal tests. Meanwhile, PF-GL-TE gel played significant preventive effects on melasma induced by progesterone injection and ultraviolet radiation B (UVB) irradiation. According to the results of H&E staining and Masson staining of rat skin, PF-GL-TE gel can alleviate the skin inflammation of and reduce the loss of collagen fibers of back skin in the melasma model rats. Compared with the PF-GL mixture gel, PF-GL-TE gel significantly attenuated the oxidative damage of liver and skin by increasing the activity of SOD and reducing the content of MDA. The results of Western blot showed that PF-GL-TE gel might down-regulate melanin-related proteins expressions of MITF/TYR/TRP1 and TRP2 to prevent and treat melasma. These findings indicate that PF-GL-TE gel is an effective TDDS for delivering PF and GL into the skin, providing a promising preparation for effective prevention and treatment of melasma.

Peeling with retinoic acid in microemulsion for treatment of melasma: A double-blind randomized controlled clinical study.

OBJECTIVE: To evaluate the clinical efficacy of peeling with a microemulsion formulation containing 1% retinoic acid. MATERIALS AND METHODS: After development of the product, 60 patients with melasma were randomly divided into three groups (n = 20): Group 1-application of conventional 1% retinoic acid peeling (RA 1%). Group 2-application of 1% retinoic acid peeling in microemulsion (RA 1%M). Group 3-Application of placebo. The groups were submitted to four peeling sessions, fortnightly on Days 0, 15, 30, and 45, and analyzed at the time intervals of 0, 15, 30, 45, and 60 days. Evaluation was made by using the Melasma Area and Severity Index (MASI) and Melasma Quality of Life (MelasquoL) instrument. Hemato-biochemical parameters were also evaluated at Days 0 and 60. After obtaining the results, normality was evaluated by means of the Kolmogorov-Smirnov test and afterwards, the following tests were applied: Friedman statistical (to test the effect of the treatments on the MASI index); Wilcoxon, (for comparison between pairs to test the effect of treatments on the MelasQoL index); Kruskal-Wallis, (to test the differences between the groups); and Mann-Whitney, (comparisons between treatments). The level of significance adopted was 5% (α = 0.05). RESULTS: The three groups presented a significant reduction in the MASI index, indicating the effect of all the treatments on reducing the melasma (p < 0.001). A significant reduction in the stains was observed with the use of retinoic acid peeling delivered in microemulsion (62%) when compared with the conventional peeling with 1% retinoic acid in a conventional vehicle (26%) and the placebo (12%). There was also a significant reduction in the MelasQoL index (sum of all the aspects) in the three groups, indicating the effect of all the treatments, including the placebo, on the overall quality of life of those with melasma. However, RA 1%M the treatment that promoted the greatest effect on the quality of life of individuals. In percentage terms, the RA 1%M provided a mean reduction of 30% in the MelasQoL index, against 13% of the conventional treatment and only 4% of the placebo. When the hemato-biochemical parameters were compared on Days 0 and 60, there were no significant changes in the results. CONCLUSION: The chemical peeling performed with RA 1%M was effective for the treatment of melasma, and was shown to be superior to the peeling performed with retinoic acid in a conventional vehicle, in reducing the stains and improving the quality of life of patients.

Best practices in the treatment of melasma with a focus on patients with skin of color.

BACKGROUND: Melasma is a chronic hypermelanosis of the skin that affects approximately 1% of the global population, predominantly affects women, and is more prevalent in skin of color. Melasma is a common driver for patients with skin of color to seek out a dermatologist for treatment, and ensuring the right approach for these patients is important because some treatments may be associated with adverse side effects. Because of the chronicity of the disease and established psychosocial and emotional impacts, there is a large need to ensure care follows the best available evidence on the treatment of patients with melasma. OBJECTIVE: Here, we summarized current available topical treatments for melasma with considerations dermatologists should have for their patients with skin of color. METHODS: Steering committee consensus on clinical best practices. RESULTS: We describe a flexible and focused treatment algorithm that reflects both treatment and maintenance periods that is a consensus of our extensive clinical experience. LIMITATIONS: Use of real-world evidence and potential for individual practice bias. CONCLUSION: Melasma can be challenging to treat, particularly in patients with skin of color, and our recommendations for best practices for patients in the United States are an important step toward standardizing care.

Guide to tinted sunscreens in skin of color.

Disorders of hyperpigmentation, such as melasma and post-inflammatory hyperpigmentation, disproportionately affect skin of color and have a profound impact on quality of life. Exposure to ultraviolet light (UVL) is a well-documented factor in these disorders. However, recent studies show that visible light (VL) is a significant and underrecognized contributor to hyperpigmentation, especially in skin of color. Our objective is to review the role of VL in disorders of hyperpigmentation and that of tinted sunscreens in protecting against VL. Tinted sunscreens containing iron oxides should be recommended over nontinted sunscreens for patients prone to disorders of hyperpigmentation, as iron oxides protect against VL in addition to UVL. Tinted sunscreens are more effective than nontinted sunscreens in preventing melasma relapses and reducing hyperpigmentation, and they may also enhance the depigmenting efficacy of topical hydroquinone. In the search for an ideal tinted sunscreen for a particular patient, several factors must be considered, including a broad spectrum with adequate coverage of both UVL and VL, tint, formulation texture, active ingredients, and cost. VL is increasingly recognized as a major contributor of hyperpigmentation, and adequate treatment for disorders of hyperpigmentation should include protection against VL. Tinted sunscreens are ideal but require consideration of cosmesis, efficacy, and affordability.

The effects of supramolecular nicotinamide combined with supramolecular salicylic acid on chloasma.

OBJECTIVE: To observe the efficacy and safety of supramolecular salicylic acid monotherapy and supramolecular nicotinamide in the treatment of chloasma. METHODS: A total of 28 female patients with chloasma diagnosed in the dermatology outpatient department of our hospital were randomly divided into an experimental group and a control group, with 14 cases in each group. All patients were treated with 30% supramolecular salicylic acid every 2 weeks, for a total of 8 treatments. The experimental group was treated with 10% supramolecular nicotinamide once in the morning and once in the evening, and the control group was a blank control. Before each exfoliation treatment, subjects were photographed with a VISIA skin detector, and skin image analysis and modified melasma area and severity index (MASI) score were performed. RESULTS: According to the MMASI decrease rate (%) before and after treatment, the effective rate of the experimental group was 64.29%, and the effective rate of the control group was 14.29%. The results of the GriffithS10 and VISIA were improved. During the whole treatment, there was one mild adverse reaction in both groups. CONCLUSION: Salicylic acid stripping combined with nicotinamide in the treatment of chloasma is safe and effective, can improve skin conditions, and can be widely applied in clinical practice.

The role of 755-nm alexandrite picosecond laser in melasma management.

Melasma is a skin dyspigmentation condition that disproportionately affects women, particularly those of Latino, Black, and Asian ethnicities, significantly impacting their quality of life. Efforts to identify effective treatment options have led to the exploration of picosecond laser technology which utilizes brief pulse durations to break down pigment while minimizing thermal damage to surrounding tissue. The 755-nm alexandrite picosecond laser, currently FDA approved for benign pigmented lesion removal, including melasma, is a promising solution. We aim to assess the efficacy and safety of the 755-nm alexandrite picosecond laser both as a stand-alone treatment for melasma and in combination with topical agents. We conducted a PubMed search using "755-nm picosecond" AND "melasma," "755-nm picosecond" AND "hydroquinone," and "755-nm picosecond" AND "tranexamic acid." English-written studies examining this laser as monotherapy or in combination with the topical agents were included. Those not meeting the criteria or lacking data related to melasma improvement were excluded. Monotherapy with the 755-nm picosecond laser led to a 50-75% improvement in melasma appearance in 40% of participants and a significant reduction in the average Melasma Area and Severity Index (MASI) score (p < 0.001) in all patients of one study. Notably, the use of topical tranexamic acid (TTA) in conjunction with the picosecond laser exhibited the most significant degree of improvement in hemi-MASI scores compared to the laser monotherapy group at one- and three-months post-treatment (p < 0.05). Patient satisfaction was also significantly higher for the combination group (p < 0.05). In contrast, combining hydroquinone (HQ) with the picosecond laser demonstrated no significant difference in outcomes compared to HQ alone, both of which were less effective than TTA with picosecond laser. The combination of the 755-nm picosecond laser with TTA proves promising, outperforming both laser monotherapy and laser with HQ. While monotherapy with the picosecond laser or topical agents is effective, literature favors combination therapy, especially the 755-nm picosecond laser with TTA, for superior benefits and minimal side effects. Ultimately, individualized regimens, considering factors like skin type, should be prioritized, given the heightened risk of postinflammatory hyperpigmentation, especially in skin of color patients.

Topical Treatments for Melasma and Post-inflammatory Hyperpigmentation.

BACKGROUND: Dyschromia is one of the most common reasons for patients to seek dermatological care, especially among individuals with skin of color. Most cases present as melasma or post-inflammatory hyperpigmentation (PIH); both are chronic issues requiring long-term treatment. While many pharmaceutical (topical or systemic) or procedural (lasers/chemical peels) options are available, some treatments are not safe/tolerable for long-term use or can induce/exacerbate PIH.  Methods: This qualitative review provides an overview of topical treatments for melasma and PIH, including recent data from an investigator-initiated trial of the retinoid tazarotene.  Results: Topical hydroquinone (HQ) in the form of triple combination HQ 4%/tretinoin 0.05%/fluocinolone acetonide 0.01% cream is the gold-standard treatment for melasma and PIH but should not be used long-term due to safety concerns. Efficacy data for OTC/cosmeceutical products are limited or lacking. Topical retinoids are efficacious and safe, though dose and formulation differences may affect tolerability. Tazarotene 0.045% polymeric emulsion lotion demonstrated good efficacy, safety, and tolerability over 24 weeks in adult female patients with moderate-to-severe melasma and/or PIH. CONCLUSIONS: There are multiple topical treatments available for dyspigmentation. However, many are lacking efficacy data and others are limited by tolerability or safety concerns. Retinoids, such as tazarotene, may be an efficacious and safe treatment for melasma or PIH. J Drugs Dermatol. 2023;22(11):1118-1123     doi:10.36849/JDD.7754.

Assessment of the Efficacy of Tranexamic Acid Solution 5% in the Treatment of Melasma in Patients of South Asian Descent.

Melasma is a common dermatologic condition affecting all skin types. Increasing rates of melasma warrant identification of a reliable topical treatment. In recent years, off-label tranexamic acid (TA) has emerged as a potential treatment of melasma. Although the mechanism of action remains unclear, it is thought that TA inhibits melanin synthesis by blocking the interaction between melanocytes and keratinocytes while reversing the abnormal dermal changes associated with melasma. Our study assessed the efficacy of TA solution 5% for the treatment of melasma in patients with darker skin types.

Efficacy of photorejuvenation combined with tranexamic acid and hydroquinone cream in the treatment of complex facial pigmentation.

The aim of this study was to assess the effectiveness of photo rejuvenation combined with tranexamic acid and hydroquinone cream in the treatment of complex facial pigmentation. A total of 108 patients with complex facial pigmentation between October 2019 and October 2021 were included in this retrospective study and divided into 2 groups according to the treatment that they received, with 54 cases in each group. The control group received treatment with tranexamic acid and hydroquinone cream. On the basis of the control group, the observation group was treated with photo rejuvenation combined with tranexamic acid and hydroquinone cream. The effectiveness of the treatments in both groups was determined through photographs and melasma area severity index score. The skin conditions were also compared before and after treatment. The effective rate of the observation group was significantly higher than that of the control group (98.15% vs 83.33%, P = .025). The melasma area and severity index score in the observation group was significantly lower than that in the control group after treatment (1.58 ±â€…0.14 vs 2.96 ±â€…0.13, P < .001). Before treatment, there was no significant difference in the skin elasticity and skin water content between the observation group and control group (P > .05). After treatment, the skin elasticity and skin water content were significantly higher than that in the control group (P < .05). Photo rejuvenation combined with tranexamic acid and hydroquinone cream has a significant curative effect on patients with complex facial pigmentation, which can significantly improve skin elasticity, increase skin water content, and reduce the degree of skin lesions.

Efficacy and safety of the combination of tranexamic acid injection and electro-optical synergy (ELOS) versus tranexamic acid injection alone in the treatment of melasma.

Melasma is a common, relapsing, multifactorial disease for which the treatment decision remains extremely difficult. This study was designed to compare the efficacy and safety of the combination of tranexamic acid (TA) injection and electro-optical synergy (ELOS) versus TA injection alone in treating melasma. A retrospective study was undertaken for patients with facial epidermal or mixed-type melasma to compare clinical data between 15 patients receiving a combination regimen and 15 patients with TA injection only. The study administered TA through intravenous injection to the combination group (twice weekly for 12 weeks) followed by ELOS therapy (once a month for three times). The TA group, on the other hand, received only TA injection (twice weekly for 12 weeks). The evaluation of clinical effectiveness was based on comparing the Melasma Area Severity Index (MASI) scores before and one month after treatment (at 4 months). The Physician Global Assessment (PGA) and Patient satisfaction were documented, and adverse reactions were recorded. All patients were followed up for one year to observe the relapse. After treatment, the MASI scores and melasma severity were significantly reduced in both groups. The combination group showed better efficacy than the TA only group (P < 0.05). The Physician Global Assessment (PGA) and Patient satisfaction showed superior efficacies of the combination group. No significant difference was observed between the two groups in terms of treatment-related side effects. Both groups experienced a certain degree of recurrence during the one-year follow-up, but the TA only group had a significantly higher recurrence rate than the combination group (P < 0.01). Together, the combination of TA injection and ELOS is a safe and effective treatment strategy for melasma and should be promoted.

Prescribing practices of tranexamic acid for melasma: Delphi consensus from the Pigmentary Disorders Society.

Introduction There is ambiguity regarding usage of tranexamic acid for melasma in India, be it in its pre-administration evaluation, administration route, dosing or monitoring. Hence, we conducted this study to understand various tranexamic-acid prescribing patterns and provide practical guidelines. Materials and methods A Google-form-based questionnaire (25-questions) was prepared based on the key areas identified by experts from the Pigmentary Disorders Society, India and circulated to practicing dermatologists across the country. In rounds 2 and 3, the questionnaire was re-presented to the same group of experts and their opinions were sought. The results of the practitioners' survey were denoted graphically alongside, to guide them. Consensus was deemed when at least 80% of respondents chose an option. Results The members agreed that history pertaining to risk factors for thromboembolism, cardiovascular and menstrual disorders should be sought in patients being started on oral tranexamic-acid. Baseline coagulation profile should be ordered in all patients prior to tranexamic-acid and more exhaustive investigations such as complete blood count, liver function test, protein C and S in patients with high risk of thromboembolism. The preferred oral dose was 250 mg orally twice daily, which can be used alone or in combination with topical hydroquinone, kojic acid and sunscreen. Repeated dosing of tranexamic-acid may be required for those relapsing with melasma following initial tranexamic-acid discontinuation. Coagulation profile should ideally be repeated at three monthly intervals during follow-up, especially in patients with clinically higher risk of thromboembolism. Treatment can be stopped abruptly post improvement and no tapering is required. Limitation This study is limited by the fact that open-ended questions were limited to the first general survey round. Conclusion Oral tranexamic-acid provides a valuable treatment option for melasma. Frequent courses of therapy may be required to sustain results and a vigilant watch is recommended for hypercoagulable states during the course of therapy.

Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial.

BACKGROUND: Kligman's trio (KT), combining hydroquinone, retinoic acid and corticosteroid, is considered as the gold standard treatment of melasma. Its efficacy has never been matched before, but it is tempered by frequent adverse effects. OBJECTIVE: To assess the efficacy and tolerance of a New Trio (NT) combination with isobutylamido-thiazolyl-resorcinol, retinoic acid and cortosteroid compared to KT. METHODS: We conducted a 24-week monocentric trial, randomized, double-blind, controlled versus KT, with 40 melasma patients. NT and KT were applied for 12 weeks and associated with the same sunscreen applied for 24 weeks. The primary endpoint was the modified Melasma Area Severity Index (mMASI) at 12 weeks. Patient quality of life was investigated using MelasQoL. RESULTS: After 12 weeks, KT and NT groups both demonstrated a significant improvement in mMASI, respectively -2.84 (SE 0.69, p < 0.0002) and -4.33 (SE 0.71, p < 0.0001). The mean difference between the two groups was -1.49 (IC 95% -3.52 to 0.54, p = 0.14). MelasQoL improvement was -6.66 (SE 3.29, p = 0.0515) with KT and -12.57 (SE 3.29, p = 0.0006) with NT. CONCLUSION: The NT combination appears to be an effective treatment option for treating melasma and could be considered as a well-tolerated alternative to KT.

A systematic review to evaluate the efficacy of azelaic acid in the management of acne, rosacea, melasma and skin aging.

BACKGROUND: Topical azelaic acid (AA) is indicated for acne and rosacea, but there is some evidence for its use for other dermatological conditions. AIMS: To assess the effectiveness and safety of topical AA for acne vulgaris, rosacea, hyperpigmentation/melasma, and skin aging. METHODS: RCTs of at least 6 weeks' treatment duration were eligible for inclusion. Databases including MEDLINE, Embase, CINAHL, and ClinicalTrials.gov were searched up to December 2022. Two reviewers were involved in all stages of the systematic review process. RESULTS: Forty-three RCTs met the inclusion criteria. Meta-analyses within 20 rosacea studies demonstrated that erythema severity, inflammatory lesion counts, overall improvement, and treatment success (achieving skin clarity) were significantly improved with AA compared with vehicle after 12 weeks. AA was more effective than metronidazole 0.75% for improved erythema severity, overall improvement, and inflammatory lesion counts. Sixteen acne studies suggest that AA is more effective than vehicle for improving global assessments and reducing acne severity. AA 20% also significantly reduced more lesions than erythromycin gel. Within seven melasma studies, AA 20% was significantly better than vehicle for both severity and global improvement. AA 20% demonstrated significantly better results compared with hydroquinone 2% for global improvement. Very few significant differences between AA and comparators were observed for commonly reported adverse events. No eligible RCTs were found that evaluated skin aging. CONCLUSIONS: AA is more effective than vehicle for rosacea, acne and melasma. Comparisons between AA and other treatments were often equivalent. Where there is equivalence, AA may be a good option for some clinical situations. RCT evidence is needed to evaluate the effectiveness of AA on skin aging.