A Split-Face Comparative Study in Efficacy and Safety between the Combination of 4% Niacinamide and 4% Kojic Acid Cream versus 4% Hydroquinone Cream for Epidermal Melasma

R. Hindritiani, Felly Nazlia, Nadia Octavia, Trustia Rizqandaru, D. Puspitosari, K. Ruchiatan
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Abstract

Background: Melasma is a hyperpigmentation disorder that affects the quality of life, especially in women. Hydroquinone has remained the mainstay of melasma treatment. However, its safety for long-term usage became a great concern. Combination therapy, such as niacinamide and kojic acid, can be used as an alternative melasma treatment due to different mechanisms of action and synergism. Purpose: The aim of this study was to compare the efficacy and safety of a combination of 4% niacinamide and 4% kojic acid (N-K) vs. 4% hydroquinone (HQ) in epidermal melasma. Methods: This was a randomized, double blind, clinical study on 13 female epidermal melasma patients at the Cosmetic Dermatology Outpatient Clinic of Dr. Hasan Sadikin Hospital, Bandung. Patients received two creams, a combination of N-K and HQ, for split-face therapy, regardless of the sides of the face. All patients were followed up at 4 and 8 weeks. The clinical efficacy was assessed for skin lightening effects using a spectrophotometer (L* value) and the melasma area severity index (MASI). Adverse effects were assessed in all patients. Result: Both the N-K and HQ groups showed significant improvement in skin lightening and MASI scores on week 8 (p <0.05). There was no statistically significant difference in efficacy between the N-K and HQ groups (p >0.05). None of the patients in the N-K group complained of any adverse effects. Whereas in the HQ group, 23.07% presented with pruritus and mild erythema.
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4%烟酰胺和4%曲酸乳膏与4%对苯二酚乳膏联合治疗表皮黄褐斑的疗效和安全性对比研究
背景:黄褐斑是一种影响生活质量的色素沉着症,尤其是女性。对苯二酚一直是治疗黄褐斑的主要药物。然而,其长期使用的安全性成为人们非常关注的问题。烟酰胺和曲酸联合治疗由于其作用机制和协同作用不同,可作为黄褐斑的替代治疗方法。目的:本研究的目的是比较4%烟酰胺和4%曲酸(N-K)与4%对苯二酚(HQ)联合治疗表皮黄褐斑的疗效和安全性。方法:这是一项随机、双盲的临床研究,研究对象是万隆哈桑·萨迪金医生医院美容皮肤科门诊的13名女性表皮黄褐斑患者。患者接受两种面霜,N-K和HQ的组合,用于面部分裂治疗,无论面部的两侧如何。所有患者均于第4周和第8周随访。采用分光光度计(L*值)和黄褐斑面积严重指数(MASI)评估临床疗效。对所有患者的不良反应进行评估。结果:N-K组和HQ组在第8周皮肤亮度和MASI评分均有显著改善(p < 0.05)。N-K组中没有患者抱怨有任何不良反应。而HQ组23.07%出现瘙痒和轻度红斑。
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