Efficacy and Safety of Nicotinamide 10%, Associated with Magnesium Ascorbyl Phosphate 5% and Hyaluronic Acid 5%, Compared to Hydroquinone 4% in Women with Facial Melasma: A Randomized, Double-Blind, Controlled Clinical Trial.

IF 1.9 4区医学 Q3 DERMATOLOGY

Clinical, Cosmetic and Investigational Dermatology Pub Date : 2024-10-03 eCollection Date: 2024-01-01 DOI:10.2147/CCID.S473224

Mayla Barbosa, Rebecca Perez de Amorim, Daniel Cassiano, Marina Dias, Ana Flávia de Abreu, Edileia Bagatin, Hélio Amante Miot, Ana Cláudia Cavalcante Espósito

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引用次数: 0

Abstract

Background: Nicotinamide has demonstrated efficacy in the treatment of melasma. Topical antioxidants and humectants may enhance its performance. Currently, there is no controlled trial on the combination of 10% nicotinamide, 5% magnesium ascorbyl phosphate, and 5% hyaluronic acid, a dermo-cosmetic compound, in comparison to 4% hydroquinone for the treatment of melasma. This study aimed to explore the tolerability and efficacy of the association of the combined product versus hydroquinone.

Methods: A randomized, double-blind trial involving women with facial melasma was conducted. Participants were instructed to apply the combined product (NIC group) twice daily or 4% hydroquinone for 60 days (HQ group) at night and placebo in the morning. Evaluations were performed at inclusion, after 14 and 60 days of treatment, measuring the modified Melasma Area and Severity Index (mMASI), Melasma Quality of Life Scale (MELASQoL), and colorimetric luminosity. The Global Aesthetic Improvement Scale (GAIS) was assessed by a blinded evaluator.

Results: Both interventions led to a progressive improvement in mMASI, MELASQoL, and GAIS, without a difference between them on D14 and D60 (p>0.2). For NIC, the mean reduction (95% CI) in mMASI was 16% (8-24%) on D14 and 32% (23-41%) on D60, while for HQ, it was 10% (7-24%) on D14 and 43% (34-52%) on D60. Reduction in colorimetric luminosity was greater in the HQ group at D60 (p=0.01). No serious side effects were identified. Of the initially included 50 patients, one was lost to follow-up in the HQ group on D60, and one withdrew consent from the NIC group, both unrelated to treatment.

Conclusion: The association of 10% nicotinamide, 5% magnesium ascorbyl phosphate, and 5% hyaluronic acid was safe and well-tolerated, although its overall clinical efficacy was numerically inferior to 4% hydroquinone. This regimen can be considered for patients with poor tolerability to hydroquinone.

Clinical trial registration: #RBR-4mkfmr8.

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尼古丁酰胺 10%、抗坏血酸磷酸镁 5%、透明质酸 5%，与氢醌 4%相比，对面部黄褐斑女性的疗效和安全性：一项随机、双盲、对照临床试验。

背景：尼古丁酰胺对治疗黄褐斑有明显疗效。外用抗氧化剂和保湿剂可提高其疗效。目前，还没有关于 10%烟酰胺、5%抗坏血酸磷酸镁和 5%透明质酸（一种皮肤美容复合物）联合治疗黄褐斑与 4% 氢醌比较的对照试验。本研究旨在探讨联合产品与氢醌的耐受性和疗效：方法：进行了一项随机双盲试验，参与者包括面部有黄褐斑的女性。受试者被要求在晚上使用联合产品（NIC 组），每天两次；或在 60 天内使用 4% 氢醌（HQ 组），早上使用安慰剂。在纳入时、治疗 14 天和 60 天后进行评估，测量改良黄褐斑面积和严重程度指数（mMASI）、黄褐斑生活质量量表（MELASQoL）和比色亮度。全球美学改善量表（GAIS）由一名盲人评估员进行评估：结果：两种干预方法都能逐步改善 mMASI、MELASQoL 和 GAIS，但在第 14 天和第 60 天没有差异（P>0.2）。对 NIC 而言，mMASI 的平均下降率（95% CI）在 D14 为 16% (8-24%)，在 D60 为 32% (23-41%)；对 HQ 而言，在 D14 为 10% (7-24%)，在 D60 为 43% (34-52%)。在 D60 时，HQ 组的比色光度降低幅度更大（P=0.01）。未发现严重副作用。在最初纳入的 50 名患者中，HQ 组有一人在 D60 时失去随访，NIC 组有一人撤回同意，均与治疗无关：结论：10%烟酰胺、5%抗坏血酸磷酸镁和5%透明质酸联合疗法安全且耐受性良好，但其总体临床疗效在数量上不如4%氢醌。对于氢醌耐受性较差的患者，可以考虑使用这种疗法：临床试验注册号：#RBR-4mkfmr8。

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来源期刊

Clinical, Cosmetic and Investigational Dermatology Medicine-Dermatology

CiteScore

2.80

自引率

4.30%

发文量

353

审稿时长

16 weeks

期刊介绍： Clinical, Cosmetic and Investigational Dermatology is an international, peer-reviewed, open access journal that focuses on the latest clinical and experimental research in all aspects of skin disease and cosmetic interventions. Normal and pathological processes in skin development and aging, their modification and treatment, as well as basic research into histology of dermal and dermal structures that provide clinical insights and potential treatment options are key topics for the journal. Patient satisfaction, preference, quality of life, compliance, persistence and their role in developing new management options to optimize outcomes for target conditions constitute major areas of interest. The journal is characterized by the rapid reporting of clinical studies, reviews and original research in skin research and skin care. All areas of dermatology will be covered; contributions will be welcomed from all clinicians and basic science researchers globally.