A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma

Background  Melasma is an acquired, chronic hypermelanosis for which therapy remains a challenge.
Objectives  To compare the efficacy and safety of a triple combination [TC: fluocinolone acetonide 0·01%, hydroquinone (HQ) 4%, tretinoin 0·05%] vs. HQ 4% after 8 weeks of treatment of moderate to severe facial melasma in Asian patients.
Methods  This was a multicentre, randomized, controlled, investigator-blinded, parallel comparison study. East and South-East Asian patients aged 18 years or older, with a clinical diagnosis of moderate to severe melasma, were enrolled in this study. Patients were enrolled at baseline and treated daily for 8 weeks with TC cream (one application at bedtime) or HQ cream (twice daily). There were four study visits: at baseline and weeks 2, 4 and 8. The primary efficacy variable was the melasma global severity score (GSS). Other outcome measures included Melasma Area and Severity Index, global improvement and patient satisfaction. Safety was assessed through the reporting of adverse events.
Results  TC had superior efficacy to HQ for the primary variable: 77/120 patients (64·2%) on TC had GSS 'none' or 'mild' at week 8 vs. 48/122 patients (39·4%) on HQ ( P  < 0·001). The secondary efficacy variables confirmed these results. Patient satisfaction was in favour of TC (90/127, 70·8%, vs. 64/129, 49·6%; P  = 0·005). More patients had related adverse events on TC (63/129, 48·8%) than on HQ (18/131, 13·7%) but most were mild and none was severe.
Conclusions  Efficacy in Asians and patient satisfaction were superior with the fixed TC than with HQ 4%.     

Comparative study of therapeutic effects of 20% azelaic acid and hydroquinone 4% cream in the treatment of melasma

Background Melasma is an irregular brown or grayish‐brown symmetric facial hypermelanosis, often affecting women, especially those living in areas with intense ultraviolet radiation. Objective Comparison of therapeutic effects of 20% azelaic acid and 4% hydroquinone cream in the treatment of melasma. Methods Twenty‐nine women with melasma were recruited. Fifteen patients were treated with 4% hydroquinone cream and 14 patients were treated with azelaic acid cream for 2 months. The cream was applied twice daily. A broad‐spectrum sunscreen was used concomitantly by both groups. The Melasma Area Severity Index (MASI) scores were determined prior to treatment and at each follow‐up. Results The mean MASI score before treatment was 7.2 ± 3.2 in the hydroquinone group and 7.6 ± 3.5 in the azelaic acid group, with no significant difference between them (t‐test, CI 95% = ?2.9 to 2.2). One month after treatment, the mean MASI score reached 6.7 ± 3.4 with hydroquinone and 6.3 ± 3.4 with azelaic acid with no significant difference between them (t‐test, CI 95% = ?2.2 to 3). After 2 months’ treatment, the MASI score was 6.2 ± 3.6 with hydroquinone and 3.8 ± 2.8 with azelaic acid, a significant statistical difference (t‐test, CI 95% = 0.03–4.9). Conclusions In conclusion, this study suggests that 20% azelaic acid cream applied twice daily may be more effective than hydroquinone 4% in reducing mild melasma. However, because this was an open trial, it is suggested that further studies involving large groups of patients be conducted to achieve a more conclusive result.     

Combined trichloroacetic acid peel and topical ascorbic acid versus trichloroacetic acid peel alone in the treatment of melasma: a comparative study

Background Melasma is a common acquired hypermelanosis that is difficult to treat. Several chemical peeling agents were used in treatment of melasma. Topical vitamin C was also used with minimal side effects. Aim To compare the effect of 20% trichloroacetic acid (TCA) peel alone vs. 20% TCA peel combined with topical 5% ascorbic acid in cases of epidermal melasma. Patients and methods Thirty women with bilateral epidermal melasma (Fitzpatrick skin types III and IV) were divided into two groups (A and B, 15 patients each). Before therapy, digital photography and a melasma area and severity index (MASI) score were done for each patient. Groups A and B were primed for 2 weeks before TCA peel. Group B also applied 5% ascorbic acid topically once daily; 20% TCA peel was done for all patients weekly until clearance of melasma or for a maximum of six peels. Group B continued to use 5% ascorbic acid topically in between peels and during the 16‐week follow‐up period. Patients were assessed at the end of peeling sessions and at the end of follow‐up by photography, MASI score, and a global evaluation by the patient. Results Group B compared with group A showed a significant decrease in MASI score at the end of TCA peels (P < 0.001) and at the end of the 16‐week follow‐up period (P < 0.003). Global evaluation showed that 13 patients (87%) in group B improved or maintained their improvement compared with only 10 patients (67%) in group A. Conclusion Topical ascorbic acid combined with 20% TCA peel in melasma improves the results and helps in maintaining the response to therapy.     

A randomized and placebo-controlled study to compare the skin-lightening efficacy and safety of lignin peroxidase cream vs. 2% hydroquinone cream

Background Historically, the most effective treatments for skin lightening have contained hydroquinone. However, there is a need for an effective alternative. Aims The purpose of this study was to evaluate the skin‐lightening efficacy and safety of lignin peroxidase (LIP) creams using a regimen of both day and night products compared with twice‐daily application of 2% hydroquinone cream and placebo in Asian women. Patients/Methods This was a randomized, double‐blind, placebo‐controlled, split‐face, single‐center study of 51 patients. Patients were randomized to receive day and night LIP cream on one randomly selected side of their face and either 2% hydroquinone cream or placebo on the other. Results A statistically significant change from baseline in the melanin index was observed in LIP‐treated skin, with a mean reduction of 7.6% (P < 0.001) on Day 31. Conversely, hydroquinone and placebo did not provide a statistically significant lightening effect when instrumentally measured. Dermatologist scoring demonstrated a significant improvement in overall fairness as early as 8 days after treatment initiation in the LIP‐treated group, which was not observed in the other groups. Overall, patients preferred the LIP creams. Conclusions The application of day/night LIP cream provided a significantly more rapid and observable skin‐lightening effect than hydroquinone 2% cream or placebo.     

A microsponge formulation of hydroquinone 4% and retinol 0.15% in the treatment of melasma and postinflammatory hyperpigmentation

Disorders of hyperpigmentation such as melasma and postinflammatory hyperpigmentation (PIH) are common, particularly among people with darker skin types. Hydroquinone (HQ) bleaching creams are considered the gold standard for treating hyperpigmentation. Recently, a new formulation of HQ 4% with retinol 0.15% entrapped in microsponge reservoirs was developed for the treatment of melasma and PIH. Microsponges were used to release HQ gradually to prolong exposure to treatment and to minimize skin irritation. The safety and efficacy of this product were evaluated in a 12-week open-label study. A total of 28 patients were enrolled, and 25 completed the study. Study end points included disease severity, pigmentation intensity, lesion area, and colorimetry assessments. Adverse events also were recorded. Patients applied the microentrapped HQ 4% formulation to the full face twice daily (morning and evening). A broad-spectrum sunscreen was applied once in the morning, 15 minutes after application of the test product. Patients were evaluated at baseline and at 4, 8, and 12 weeks. The microentrapped HQ 4%/retinol 0.15% formulation produced improvement at all study end points. Improvement in disease severity and pigmentation intensity was statistically significant at weeks 4, 8, and 12 compared with baseline (P<.001). Lesion area and colorimetry measurements also were significantly improved at each visit (P<.001). Microentrapped HQ 4% was well tolerated, with only one patient discontinuing because of an allergic reaction, which was not considered serious. In this open-label study, microentrapped HQ 4% with retinol 0.15% was safe and effective.     

贝复新联合曲安奈德益康唑乳膏治疗面部湿疹临床研究

目的:评价贝复新联合曲安奈德益康唑乳膏治疗面部湿疹的临床疗效及安全性。方法:107例患者随机分为治疗组(57例)和对照组(50例),治疗组外用贝复新联合曲安奈德益康唑乳膏,对照组仅外用曲安奈德益康唑乳膏。结果:治疗2周后,治疗组症状体征评分为1.23±1.65,明显低于对照组的2.22±2.14,差异有统计学意义(P0.05)。治疗组有效率为87.72%,高于对照组的70%,差异有统计学意义(P0.05)。两组患者均未见明显不良反应。结论:贝复新联合曲安奈德益康唑乳膏治疗面部湿疹优于单用曲安奈德益康唑乳膏。