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.

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.

Magnesium ascorbyl phosphate vesicular carriers for topical delivery; preparation, in-vitro and ex-vivo evaluation, factorial optimization and clinical assessment in melasma patients.

Ascorbic acid (vitamin C) is an antioxidant that is widely used in cosmetics in skincare products. Due to the excessive low stability of ascorbic acid in cosmetic formulations, the stabilized ascorbic acid derivative, magnesium ascorbyl phosphate (MAP) was formulated as vesicular carriers; ethosomes and niosomes. The aim was to deliver MAP at the intended site of action, the skin, for sufficient time with enhanced permeation to get an effective response. Ethosomes were formulated using a full 32 factorial design to study ethanol and phospholipid concentration effect on ethosomes properties. Niosomes were formulated using 23 factorial designs to study the effect of surfactant type, surfactant concentration and cholesterol concentration on niosomes properties. The prepared formulations were evaluated for their Entrapment efficiency, particle size, polydispersity index, zeta potential and % drug permeated. The optimized ethosomal and niosomal formulations were incorporated into carbopol gel and evaluated for their permeation, skin retention and stability. A comparative split-face clinical study was done between the ethosomal and niosomal formulations for melasma treatment using Antera 3 D® camera. The optimized ethosomal and niosomal gels showed comparable controlled permeation and higher skin retention over their ethosomes and niosomes formulations respectively. Magnesium ascorbyl phosphate ethosomal gel showed clinically and statistically significant melanin level decrease after one month while MAP niosomal gel showed clinically and statistically significant melanin level decrease after six months. A combination of MAP ethosomes and niosomes could be promising skincare formulations for melasma and hyperpigmentation short and long-term treatment.

Hispanic/Latinos and Skincare: Disparities in Product Development, Marketing, and Toxicity.

“Hispanic” and “Latino” (also known as Mestizo) describe a diverse racial and ethnic group, with a range of cultures, languages, and biological ancestry. It includes individuals of Mexican, Central-to-South American, and Spanish-Caribbean (eg, Cuban, Puerto Rican, and Dominican) descent.1 Individuals of Hispanic/Latino race and ethnicity represent a heterogenous group of people with different skin tones and Fitzpatrick phototypes. Hispanic/Latinos are the fastest growing population in the United States (US) - projected to increase from 55 million in 2014 to 119 million in 2060, an increase of 115%.2 By 2060, more than one-quarter (29%) of the US is projected to be Hispanic/Latino.2.

Assessment of the efficacy and tolerance of a new combination of retinoids and depigmenting agents in the treatment of melasma.

BACKGROUND: Melasma is a dermatosis with significant repercussions on patients' quality of life, and there is currently no standard treatment. Hydroquinone is deemed the treatment of choice, but its safety has been questioned in certain cases. AIMS: To determine the efficacy and safety of a new combination of retinoids in the improvement of melasma. PATIENTS/METHODS: Prospective, double-blind, vehicle-controlled, and randomized study in 30 patients with melasma. The product was applied on one side of the face and the vehicle on the other, twice daily during 3 months. Standardized photographs were taken using RBX technology on the three visits (basal, at one and a half months and at 3 months). The main variable to determine the efficacy was the improvement of the hemifacial Melasma Area Severity Index (MASI). Other variables were determined such as improvement perceived by the investigator, improvement perceived by the patient, impact on quality of life or side effects. RESULTS: The MASI improvement at 3 months of treatment was significant on the treated side vs. the vehicle side, reaching an improvement of 70%, which is comparable to the percentage of improvement described with hydroquinone. No notable side effects were detected, in spite of a significant percentage of patients included in the study citing a history that could be compatible with sensitive skin. CONCLUSIONS: This new combination of retinoids and depigmenting agents proved to be effective and safe in the treatment of melasma.

Objective assessment of erythema and pigmentation of melasma lesions and surrounding areas in long-term management regimens with triple combination.

BACKGROUND: Melasma has a negative impact on quality of life since it typically occurs on the face. OBJECTIVES: To evaluate the erythema and pigmentation of melasma lesions and the surrounding areas in patients receiving triple combination (TC: hydroquinone, tretinoin, and fluocinolone acetonide) regimens. METHODS: Patients first received an 8-week daily TC treatment and were then randomized to twice weekly or tapering regimen with TC. Melanin and erythema levels of lesions and surrounding areas were objectively measured using a narrowband reflectance spectrophotometer. RESULTS: Progressive reduction in the mean melanin levels was observed in the treatment phase. Following both maintenance regimens, there was no difference between melanin levels in the melasma lesions. Adverse effects were rare in both phases of the study and there was borderline reduction in erythema with regimen II. CONCLUSION: Both maintenance regimens were effective in maintaining results obtained during the initial treatment phase, and were safe and well-tolerated. Erythema was less intense with the tapering regimen.

A pilot study using reflectance confocal microscopy (RCM) in the assessment of a novel formulation for the treatment of melasma.

INTRODUCTION: Melasma is a common pigmentary disorder caused by abnormal melanin deposits within the skin. Hydroquinone (HQ) is presently the most popular depigmenting agent, however the treatment of melasma remains unsatisfactory, resulting in a need to evaluate new depigmenting agents. OBJECTIVE: The objective of this study was to assess, using standard methods and a novel technique, in vivo Reflectance Confocal Microscopy (RCM), the efficacy and safety of a new non-HQ bleaching agent Dermamelan® (Mesoestetic, Barcelona, Spain) in the treatment of melasma. METHODS: Ten women with melasma were enrolled in an open-label trial lasting four months. Patients were of Fitzpatrick skin types II-IV. A non-HQ depigmenting agent (Dermamelan) was applied once-daily for three months. Melasma Area and Severity Indices (MASI) were measured. Standard and UV-light photographs were taken and in vivo RCM, which detects pigmentary changes at a cellular level, was done. Evaluations were performed before treatment, on the first, second and third month of treatment and one month after treatment. Upon cessation of the trial, patients completed a questionnaire regarding efficacy and tolerance. RESULTS: At baseline, RCM detected hyperpigmented keratinocytes in all patients, dendritic cells in 2/10 patients, and melanophages in 2/10 patients. Based on the MASI score, Dermamelan treatment improved melasma by 50 percent. This was confirmed by standard and UV-light photography. Maximum therapeutic effect was usually reached by one month of treatment and was maintained at one month following its completion. Interestingly Dermamelan treatment also induced a statistically significant decrease of pigmented epidermal keratinocytes as detected by RCM. Patients with melanophages on RCM at baseline had a poorer outcome, but not those with dendritic cells. Mild irritation was the only adverse event observed during treatment. The majority of patients were satisfied with the result. CONCLUSION: This study suggests that Dermamelan produces significant rapid improvement of melasma at a clinical and cellular level and demonstrates the potential of RCM to monitor and possibly predict efficacy of a new depigmenting agent in the treatment of melasma.

Cost-effectiveness of a hydroquinone/tretinoin/fluocinolone acetonide cream combination in treating melasma in the United States.

BACKGROUND: Melasma, a disorder of facial hyperpigmentation, presents a treatment obstacle to many physicians. Combination therapy with hydroquinone, tretinoin, and fluocinolone acetonide has proven effective, but it is generally more expensive than other treatments. OBJECTIVE: To assess the cost-effectiveness of daily triple combination therapy (TCT) compared with daily use of each possible pair of agents (dyads) and twice daily use of hydroquinone (HQ) alone from a payer's perspective. METHODS: Efficacy data were obtained from two clinical trials with the primary endpoint being complete clearance at 8 weeks. For all treatments, total cost per successful treatment was calculated. The incremental cost-effectiveness ratio (ICER) was calculated for each dyad and for HQ monotherapy in comparison with TCT. Sensitivity analyses for efficacy and number of office visits were similarly performed. RESULTS AND CONCLUSION: TCT consistently had the lowest cost per primary success in all the analyses performed. Furthermore, ICERs were low, indicating that TCT's superior efficacy is attained at marginal cost increases. Our results indicate that TCT is the most cost-effective treatment when compared with any of its dyads or with hydroquinone alone.

Cost-effectiveness of a fixed combination of hydroquinone/tretinoin/fluocinolone cream compared with hydroquinone alone in the treatment of melasma.

BACKGROUND: A once-daily fixed combination of hydroquinone, tretinoin, and fluocinolone acetonide (Tri-luma) is a newly available treatment for melasma. OBJECTIVE: To assess cost-effectiveness of triple combination therapy (TCT) applied once daily and hydroquinone alone applied twice daily in the U.S., Argentina, Brazil, Chile, and Colombia from a payer's perspective. METHODS: Clinical data and utilization of key health resources (medication only) were assessed within an 8-week clinical trial conducted in Brazil. Total cost per primary success (complete clearing) was used to compare each treatment with not treating and incremental cost effectiveness ratios were used to compare between treatments. RESULTS AND CONCLUSION: TCT had a 30% better rate of complete clearing than hydroquinone with a lower cost in the U.S. and an incremental cost in other countries. In every country, cost per primary success was lower for TCT than for hydroquinone. Results were robust to varying assumptions of success rates and quantity used.