0.3% 4 - 正丁基间苯二酚乳膏的疗效、安全性及耐受性评估：一项关于黄褐斑的印度多中心研究
Assessment of efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream: an Indian multicentric study on melasma.
作者信息
Madan Mohan N T, Gowda Adarsh, Jaiswal Ashok Kumar, Sharath Kumar B C, Shilpashree P, Gangaboraiah Bilugumba, Shamanna Manjula
机构信息
Department of Dermatology, Dr BR Ambedkar Medical College (BRAMC), Bangalore, Karnataka, India.
Department of Dermatology, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, Karnataka, India.
出版信息
Clin Cosmet Investig Dermatol. 2016 Jan 21;9:21-7. doi: 10.2147/CCID.S89451. eCollection 2016.
INTRODUCTION
Melasma is one of the commonly reported pigmentory disorders in the Indian population. Numerous therapeutic modalities are available. However, very few have produced complete satisfactory response. 4-n-Butylresorcinol 0.3% cream has recently been introduced in India as a new hypopigmenting agent. It is a resorcinol derivative and acts by inhibiting both tyrosinase and tyrosinase-related protein-1.
OBJECTIVE
The available published literatures are with 4-n-butylresorcinol 0.1% cream, and there is paucity of clinical studies with 4-n-butylresorcinol 0.3% cream. Furthermore, considering the fact that Indian skin is more prone to irritation with hypopigmenting agents, our study explores the efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream in Indian subjects with melasma.
METHODS
Fifty-two subjects with melasma participated in this open-label, single arm, observational study. All the patients were advised twice daily application of 4-n-butylresorcinol 0.3% cream for 8 weeks over the areas of melasma. Assessment parameters included modified Melasma Area Severity Index (mMASI) score. Digital photographs of all the patients at baseline, week 4, and week 8 were taken. During this 8-week study period, all the adverse events were observed and recorded.
RESULTS
All the 52 subjects completed the study. Out of 52 subjects, 90.38% were females. The mean age of patients was 38.5±7.8 years. Mean ± standard error of MASI score measurements showed a significant decrease from baseline score of 14.73±0.59 to 11.09±0.53 after week 4 (P<0.001) and 6.48±0.43 at week 8 (P<0.001). The digital photographs of the study subjects taken at week 4 and week 8 also showed decrease in melasma pigmentation compared to baseline photograph and correlated with the changes in the mMASI score. The treatment was well tolerated by all the study subjects. No adverse reactions were reported throughout the study period.
CONCLUSION
Our data suggest that the 4-n-butylresorcinol 0.3% cream is safe, effective, and well tolerated in Indian patients with melasma.
引言
黄褐斑是印度人群中常见的色素沉着紊乱疾病之一。有多种治疗方式可供选择。然而，很少有治疗方式能产生完全令人满意的效果。0.3%的4 - 正丁基间苯二酚乳膏最近作为一种新的美白剂被引入印度。它是一种间苯二酚衍生物，通过抑制酪氨酸酶和酪氨酸酶相关蛋白 - 1发挥作用。
目的
现有的已发表文献涉及的是0.1%的4 - 正丁基间苯二酚乳膏，而关于0.3%的4 - 正丁基间苯二酚乳膏的临床研究较少。此外，考虑到印度人的皮肤更容易因美白剂而受到刺激，我们的研究探讨了0.3%的4 - 正丁基间苯二酚乳膏在患有黄褐斑的印度受试者中的疗效、安全性和耐受性。
方法
52名黄褐斑患者参与了这项开放标签、单臂观察性研究。所有患者被建议每天两次在黄褐斑区域涂抹0.3%的4 - 正丁基间苯二酚乳膏，持续8周。评估参数包括改良黄褐斑面积严重程度指数（mMASI）评分。在基线、第4周和第8周拍摄了所有患者的数码照片。在这8周的研究期间，观察并记录了所有不良事件。
结果
所有52名受试者均完成了研究。在52名受试者中，90.38%为女性。患者的平均年龄为38.5±7.8岁。mMASI评分测量的平均值±标准误差显示，在第4周后，从基线评分14.73±0.59显著降至11.09±0.53（P<0.001），在第8周时降至6.48±0.43（P<0.001）。在第4周和第8周拍摄的研究对象数码照片与基线照片相比，黄褐斑色素沉着也有所减轻，且与mMASI评分的变化相关。所有研究对象对该治疗耐受性良好。在整个研究期间未报告不良反应。
结论
我们的数据表明，0.3%的4 - 正丁基间苯二酚乳膏在患有黄褐斑的印度患者中是安全、有效的，且耐受性良好。
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