Efficacy of intradermal injection of tranexamic acid and ascorbic acid versus tranexamic acid and placebo in the treatment of melasma: A split-face comparative trial.

Background and Aims: Melasma is a common dermatologic disorder characterized by symmetrical hyperpigmented lesions on the face. Although various therapeutic options are available for melasma, its treatment remains challenging. The present study evaluated the safety and efficacy of intradermal microinjection of tranexamic acid (TA) plus ascorbic acid in treating melasma lesions compared with TA and placebo. Methods: From September 2019 to May 2020, 24 patients with symmetrical melasma were enrolled in a prospective, double-blind, split-face, randomized controlled clinical trial. Each patient received 50 mg/ml TA and 50 mg/ml ascorbic acid for one side of the face (A) and 50 mg/ml TA and placebo for the other side (B) every 2 weeks for 12 weeks. The Melasma Area and Severity Index (MASI) score, Physician Global Assessment, and pain were measured at baseline and at 4, 8, 12, and 24 weeks. Statistical analysis was done using SPSS software version 16, and data were reported as mean ± standard deviation or median and interquartile range. χ 2 and Fisher's exact tests were used to test differences between the groups. Results: Both groups experienced a significant decrease in MASI scores compared with the baseline. The MASI score was significantly less in the intervention group than the placebo group at the 8th and 12th weeks. However, burning pain was significantly more prominent in the intervention group. Conclusion: Intradermal injection of ascorbic acid combined with TA can be beneficial in treating melasma. Currently, there are numerous treatment modalities for melasma. However, the results still vary, and satisfactory outcomes are yet to be reached.

Clinical Study of a Q-Switched Neodymium-Doped Yttrium Aluminum Garnet Laser with Different Parameters in the Treatment of Chloasma: A Randomized-Controlled Trial.

Objective: To explore the clinical efficacy of a Q-switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser with different parameters in the treatment of chloasma. Methods: In this study, 30 patients with chloasma, symmetrically distributed on the left and right sides of the face and who were treated with a Fayton Q-switched 1064 nm Nd:YAG laser, were recruited. The patients were randomly selected for the treatment of facial lesions on the left and right sides of the face using a spot diameter of 9 mm and an energy density of 0.8 J/cm2 on one side, and, on the opposite side, a spot diameter of 6 mm with an energy density of 1.2 J/cm2. The laser frequency was 5 Hz and treatment was conducted once every 7-10 days and repeated eight times as a course of treatment. At the end of the course of treatment, as well as 1, 3, and 6 months after treatment, front-facing images and 45° left- and right-side images were taken, respectively. The curative effect of the treatment was evaluated using the Melasma Area Severity Index (MASI) score. Results: The results of this study showed that the total effective rate of a Fayton Q-switched 1064 nm Nd:YAG laser in the treatment of chloasma was 60%. Conclusions: Using a Q-switched 1064 nm Nd:YAG laser represents a safe and effective approach for the treatment of chloasma. The therapeutic effects of the parameter sets, that is, a spot diameter of 9 mm and an energy density of 0.8 J/cm2, and a spot diameter of 6 mm with an energy density of 1.2 J/cm2, were similar. The treatment time and average effective times of the latter were relatively shortened. Clinical Trial Registration number researchregistry6799.

A split-face comparison of fractional erbium: YAG laser plus Kligman's formula vs. Kligman's formula monotherapy for facial melasma.

Melasma is a chronic hyperpigmentation disorder. Although several treatment methods are used for patients, it remains a challenging problem for physicians. Erbium-YAG laser is one of the laser treatment methods that proved its efficacy in melasma treatment. We aimed to compare the efficacy of combining the fractional Er: YAG laser and Kligman's formula with Kligman's formula alone in the treatment of melasma. Twenty female patients with bilateral melasma were randomly treated in a split-face controlled manner with a fractional Er: YAG laser followed by Kligman's formula on one side and Kligman's formula on the other side. All patients received three laser sessions with four-week intervals. The efficacy of treatments was determined through photographs, Visioface, and Melasma Area Severity Index (MASI) score, all performed at baseline and three months after the end of laser sessions. Fractional Er: YAG laser and Kligman's formula showed a significant decrease in MASI score than Kligman's formula alone (P = 0.005). There was a significant decrease in cheek Visioface score on Er: YAG laser and Kligman's formula vs Kligman's formula (P = 0.02). However, the Patient Global Assessment Scale of both sides was not statistically significant (P = 0.23). The combination of Fractional Er: YAG laser with Kligman's formula is an effective treatment method for melasma.

A comparative study between oral tranexamic acid versus oral tranexamic acid and Q-switched Nd-YAG laser in melasma treatment: a clinical and dermoscopic evaluation.

BACKGROUND: Melasma is a common acquired disorder of pigmentation. OBJECTIVE: To compare the efficacy of oral tranexamic acid (TA) versus oral TA and Q-switched Nd: YAG laser (1064-nm wavelength) in the treatment of melasma. MATERIALS AND METHODS: Sixty patients were divided into two groups. Group A: oral TA only and group B: oral TA plus Qs-Nd: YAG laser (1064 nm) sessions. Evaluations were performed on the clinical basis including the use of Modified Melasma Area and Severity Index (m MASI) and dermoscopy. Dermoscopic examinations were performed before and after the treatment sessions as well as at the 3-month follow up visit. RESULTS: There were statistically significant differences between the two studied groups regarding the change of m MASI after treatment and at the end of follow-up (p = .036) by using dermoscopy. Epidermal type of melasma showed the best response (0.048) and telangiectasias significantly improved in both groups of patients. CONCLUSIONS: Low-fluence 1064-nm Qs-Nd:Yag laser is effective and safe line of melasma treatment. Adding oral TA may enhance its clinical efficacy and decrease its side effects or complications. Dermoscopy is an important tool in pigment detection and vascular components in melasma, as well as their response to treatment.

Therapeutic efficacy and safety of oral tranexamic acid 250 mg once a day versus 500 mg twice a day: a comparative study.

Oral tranexamic acid (TXA) 250 mg twice daily has been used effectively for 4 weeks to 6 months to treat melasma. As relapses are frequent on discontinuation, a minimum effective dose of TXA that can be used safely for long time remains unknown. We compared the efficacy of oral TXA 250 mg once daily and 500 mg twice daily given for 16 weeks in 132 (m:f 23:109) adults with melasma. 42 patients in Group-A (TXA 250 mg/d) and 46 patients in Group-B (TXA 500 mg twice/d) completed the study. They were followed up at 4-week interval for percentage reduction in baseline Melasma Area Severity Index (MASI) and at 24 and 28 weeks for relapse. Therapeutic response, for both as per-protocol and intention-to-treat analysis, was scored as very good (> 75% reduction), good (51-75% reduction), moderate (25-50% reduction), mild (< 25% reduction) or no improvement. Reduction in mean MASI score at 4 weeks was not statistically significant in Group-A but it decreased significantly 8 weeks onwards and was comparable with that in Group-B. The relapse rate was higher in Group-B (10.8%) than Group-A (4.7%) at the end of 28 weeks. Oligomenorrhoea and abdominal discomfort in few patients did not necessitate treatment discontinuation. TXA 500 mg twice daily showed early reduction in mean MASI score compared to 250 mg given once daily with comparable safety and therapeutic efficacy at 16 weeks. Open-label cross-sectional design, no control arm, small number of patients in each group, MASI score being subjective assessment tool, short duration of treatment and follow-up are study limitations.

Study of oral tranexamic acid, topical tranexamic acid, and modified Kligman's regimen in treatment of melasma.

BACKGROUND: Melasma is a pigmentary disorder affecting mainly face . Various treatment modalities available as topicals, superficial chemical peels and lasers but none till date gives promising results, until date quest for the best treatment modality is on. AIM: To study the effect of oral and topical Tranexamic acid (TXA) and modified Kligman's regimen in treatment of melasma. METHOD: Patients having melasma were enrolled after consent for voluntary participation. A detailed history and clinical examination was done. Total 60 patients were enrolled and randomized in three groups, 20 received oral TXA 250 mg twice daily, 20 topical TXA and 20 received modified Kligman's regimen for 8 weeks along with sunscreen MASI(Melasma area severity index) was calculated at baseline, at end of 4 & 8 weeks. MASI score was compared with that at the end of the study. Based on reduction in mean MASI the therapeutic response was graded. Pre and post treatment photographs was also compared. Statistical analysis done by using student square T test , ANOVA And TUKEY test. RESULTS: Reduction in MASI score was observed in all the groups but greater reduction in MASI score with modified Kligman's regimen by 30% followed with oral TXA by 25% reduction and least with topical TXA by 5%. CONCLUSION: Although modified Kligman's regimen is comparatively more efficient but due to its side effects in long term usage oral tranexamic acid could be a promising therapeutic approach for melasma.

Is There a Correlation between Severity of Melasma and Quality of Life?

BACKGROUND: Melasma is a common chronic acquired hyper melanosis. It has significant impacts on appearance, psychosocial and emotional distress, hence reducing the quality of life of the affected patients. Melasma quality of life scale (MelasQoL) is a new quality of life (QoL) questionnaire consists of 10 questions, scored from 1 to 7, with higher index scores indicating poor QoL. The severity of melasma can be assessed by the Melasma Area and Severity Index (MASI) score. AIM: We aimed to determine the correlation between the severity of melasma (MASI score) and quality of life. MATERIAL AND METHODS: This was a cross-sectional analytic study involving 30 subjects with melasma. The diagnosis was made based on history, clinical features and by Wood's lamp examination. MASI score was determined to assess the severity of melasma. Subjects answered 10 items of MelasQol questionnaire. All collected data were processed and statistically analysed by Spearman correlation test to determine the association of MASI score with MelasQoL. Association of quality of life with clinical pattern and depth of lesion were analysed by Mann Whitney test. RESULTS: There was no significant correlation between MASI score and MelasQoL (p = 0.797; r = 0.049). Likewise, there was no association of quality of life with clinical pattern type (p = 0.12) and depth of lesion (p = 0.92). CONCLUSION: There was no significant correlation between the MASI score and quality of life.

[Effect on clinical symptoms and mechanism of chloasma in premenopausal women with liver qi stagnation treated with acupoint catgut embedding].

OBJECTIVE: To explore the therapeutic effect and mechanism of acupoint catgut embedding for chloasma in premenopausal women with liver qi stagnation. METHODS: A total of 92 patients of chloasma in premenopausal women with liver qi stagnation were randomized into an observation group and a control group, 46 cases in each one.In the observation group, acupoint catgut embedding was applied at Ganshu (BL 18), Pishu (BL 20), Sanyinjiao (SP 6), also the surrounding acupuncture was performed at facial part, once a week. In the control group, vitamin C (200 mg per time, 3 times a day) and vitamin E (100 mg per time, once a day) were prescribed for oral administration. Both of the two groups were given treatment for 12 weeks. The score of chloasma area and severity index (MASI), the serum levels of follicular stimulating hormone (FSH), leuteinizing hormone (LH) and estradiol (E2) before and after treatment were observed in the two groups, and the clinical effect of the two groups were compared after 3 months of treatment. RESULTS: Finally, 44 cases in the observation group and 43 cases in the control group completed the study. The effective rate in the observation group was 88.6% (39/44), which was higher than 55.8% (24/43) in the control group (P<0.01). Compared before treatment, the MASI scores after treatment were reduced in the two groups (P<0.01, P<0.05), the MASI score in follow-up in the observation group was reduced as compared with after treatment (P<0.01), and the MASI scores after treatment and in follow-up in the observation group were lower than the control group (P<0.01). Compared before treatment, the levels of FSH and LH in follow-up were reduced (P<0.01), there was no significant difference between before treatment and in follow-up in the level of E2 in the observation group (P>0.05). There was no significant difference between before treatment and in follow-up in the levels of FSH, LH and E2 in the control group (P>0.05). In follow-up, the levels of FSH and LH in the observation group were lower than the control group (P<0.01, P<0.05), there was no significant difference in the level of E2 between the two groups (P>0.05). CONCLUSION: Acupoint catgut embedding can improve the clinical symptoms of chloasma in premenopausal women with liver qi stagnation, the mechanism may be related to regulate the serum level of sex hormone to reduce high sensitivity of melanocytes to estrogen.

Fractional erbium-doped yttrium aluminum garnet laser-assisted drug delivery of hydroquinone in the treatment of melasma.

BACKGROUND: Melasma is a difficult-to-treat hyperpigmentary disorder. Ablative fractional laser (AFL)-assisted delivery of topically applied drugs to varied targets in the skin has been an area of ongoing study and research. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of fractional erbium-doped yttrium aluminum garnet (Er:YAG) laser as an assisted drug delivery for enhancing topical hydroquinone (HQ) permeation into the skin of melasma patients. PATIENTS AND METHODS: Thirty female patients with bilateral melasma were randomly treated in a split-face controlled manner with a fractional Er:YAG laser followed by 4% HQ cream on one side and 4% HQ cream alone on the other side. All patients received six laser sessions with a 2-week interval. The efficacy of treatments was determined through photographs, dermoscopic photomicrographs and Melasma Area Severity Index (MASI) score, all performed at baseline and at 12 weeks of starting therapy. The patient's level of satisfaction was also recorded. RESULTS: Er:YAG laser + HQ showed significantly better results (p<0.005) with regard to decrease in the degree of pigmentation as assessed on the 4-point scale than HQ alone. There was a significant decrease in MASI scores on Er:YAG laser + HQ side vs HQ side. Minor reversible side effects were observed on both sides. CONCLUSION: AFL-assisted delivery of HQ is a safe and effective method for the treatment of melasma.

Combined use of two formulations containing diacetyl boldine, TGF-ß1 biomimetic oligopeptide-68 with other hypopigmenting/exfoliating agents and sunscreen provides effective and convenient treatment for facial melasma. Either is equal to or is better than 4% hydroquinone on normal skin.

BACKGROUND: Treatment of melasma remains a challenge and involves multistep approach. Diacetyl boldine (DAB) stabilizes tyrosinase in its inactive form while TGF-ß1 biomimetic oligopeptide-68 inhibits tyrosinase activity. AIMS: (1) to study the efficacy and safety of the combination use of two formulae containing two principal ingredients: DAB and TGF-ß1 biomimetic oligopeptide-68 on facial melasma, and (2) to compare their efficacy with 2% and 4% hydroquinone cream (HQ) on sun-protected normal skin. METHODS: A randomized, double-blind, 12-week comparative study of pre-/post-treatment was conducted in 40 females. Melasma was evaluated by manual MASI score and MASI score with instrumentally graded darkness at baseline, 6th week, and 12th week. The author also compared their effect with HQ on the arms, assessed their safety profile throughout the study. RESULTS: Thirty-eight subjects have completed the study. Their melasma showed improvement at the 6th week and 12th week as compared with baseline (P < 0.05). None developed severe reaction. Most subjects had temporary, mild skin reaction. About 2.6% of subjects graded themselves markedly improved, 76.3% moderately improved, and 21.1% slightly improved. Each formula showed either more efficacy or exerted faster action on pigment reduction than HQ. CONCLUSION: Combination of DAB serum at night and DAB/TGF-ß1 biomimetic oligopeptide-68/sunscreen cream in the morning and at noon was effective and safe for facial melasma. They were superior to HQ in pigment reduction.

Kojic Acid vis-a-vis its Combinations with Hydroquinone and Betamethasone Valerate in Melasma: A Randomized, Single Blind, Comparative Study of Efficacy and Safety.

BACKGROUND: Melasma is a relatively common, acquired symmetric hypermelanosis characterized by irregular light to gray-brown macules involving sun-exposed areas. Kojic acid, with its depigmenting potential due to tyrosinase inhibition and suppression of melanogenesis, has become a vital component of the dermatologists' armamentarium against melasma. AIM: To study and compare the efficacy of kojic acid 1% alone, vis-a-vis its separate combinations with 2% hydroquinone or 0.1% betamethasone valerate and a combination of all these three agents with respect to the duration of symptoms and level of pigmentation in the therapy of melasma. MATERIALS AND METHODS: Eighty patients from a single tertiary care center objectively assessed by calculating the melasma area severity index (MASI) and randomized (simple randomization) into four parallel groups (A, B, C, and D) of 20 each were prescribed once daily local application at night, (participants blinded regarding the difference in identity of interventions), as follows: Group A - kojic acid 1% cream. Group B - kojic acid 1% and hydroquinone 2% cream. Group C - kojic acid 1% and betamethasone valerate 0.1% cream. Group D - kojic acid 1%, hydroquinone 2%, and betamethasone valerate 0.1% cream. Strict photoprotection and use of a SPF 15 sunscreen was advised during the day. Patients were evaluated every 2 weeks and a fall in MASI score was calculated at the end of the study period of 12 weeks by the same investigator. RESULTS: The response was compared according to percentage decrease in MASI score. Efficacy was evaluated among the groups at the end of 3 months using bivariate analysis and calculated by using the paired 't' test. The clinical efficacy of group B was the highest followed closely by group D and group A, that of group C being the lowest. CONCLUSION: Kojic acid in synergy with hydroquinone is a superior depigmenting agent as compared with other combinations.

Resultado del tratamiento con Láser Fraxel Dual 1927 en pacientes con melasma / Laser treatment outcome with Fraxel Dual 1927 laser in patients with melasma

Introducción: Melasma es un trastorno adquirido, caracterizado por la aparición de máculas simétricas de color marrón, principalmente en áreas fotoexpuestas (centrofacial, malar y mandibular). Esta condición tiene potencial efecto sobre la autoestima y calidad de vida de quien lo porta. Objetivo: evaluar el efecto del Láser Fraxel Dual 1927 como tratamiento del melasma. Pacientes y método: revisión retrospectiva de fichas clínicas y fotografías de pacientes mujeres con melasma tratadas con 1 dosis de Láser Fraxel Dual 1927 entre los años 2010 y 2011 en el Centro Dermatológico de Clínica Las Condes. Se obtuvieron de las fichas clínicas la edad, género, fototipo de piel y niveles de energía utilizados. Se tomaron fotografías antes y después de la sesión de láser y se aplicó el score de severidad de melasma, previamente validado ( MASI modificado). Resultados: se estudiaron 10 pacientes mujeres, cuyo promedio de edad fue de 37.5 años (DE 5,15).Luego de la sesión con láser, se evidenció una disminución significativa del score MASI de 6.78 (DE 4,84) a 5.09 (DE 4,81) (p= 0.049). Conclusiones: nuestros resultados sugieren que el Laser Fraxel Dual 1927 sería una alternativa efectiva en el tratamiento del melasma. Por lo anterior, es necesario realizar nuevos estudios prospectivos para comprobar estos hallazgos y evaluar efectos adversos.

Background: Melasma is an acquired disorder, characterized by the appearance of symmetric brown patches, mainly on sunlight exposed areas of the face (midfacial, malar and mandibular areas). This condition could eventually impact on patients’ self-esteem and quality of life, encouraging the search for an effective therapy. Objective: To determine the effect of Fraxel Dual 1927 laser as treatment for melasma. Patients and method: Clinical records and pictures of patients with melasma treated with Fraxel Dual 1927 laser between 2010 and 2011 at the Dermatology Department of Clínica Las Condes, were retrospectively reviewed. Data related with age, gender, skin Fitzpatrick´s phototype, treatment energy and level used were registered from clinical records. Photos were taken before and after the laser treatment session and a previously validated severity score (modified MASI Score) was applied. Results: 10 female patients with a mean age 37.5 years old (SD 5.15 years) were studied. After laser therapy, there was evidence of statistically significant reduction of MASI score from 6.78 (SD 4.84) to 5.09 (SD 4.81) (p=0.049). Conclusions: Our results suggest Fraxel Dual 1927 laser as an effective alternative to treat melasma. It would be necessary to carry on new prospectives studies to ratify these findings and assess adverseeffects.