Mayla Barbosa, Rebecca Perez de Amorim, Daniel Cassiano, Marina Dias, Ana Flávia de Abreu, Edileia Bagatin, Hélio Amante Miot, Ana Cláudia Cavalcante Espósito
{"title":"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。","authors":"Mayla Barbosa, Rebecca Perez de Amorim, Daniel Cassiano, Marina Dias, Ana Flávia de Abreu, Edileia Bagatin, Hélio Amante Miot, Ana Cláudia Cavalcante Espósito","doi":"10.2147/CCID.S473224","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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 <i>versus</i> hydroquinone.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>#RBR-4mkfmr8.</p>","PeriodicalId":10447,"journal":{"name":"Clinical, Cosmetic and Investigational Dermatology","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457776/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Mayla Barbosa, Rebecca Perez de Amorim, Daniel Cassiano, Marina Dias, Ana Flávia de Abreu, Edileia Bagatin, Hélio Amante Miot, Ana Cláudia Cavalcante Espósito\",\"doi\":\"10.2147/CCID.S473224\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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 <i>versus</i> hydroquinone.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration: </strong>#RBR-4mkfmr8.</p>\",\"PeriodicalId\":10447,\"journal\":{\"name\":\"Clinical, Cosmetic and Investigational Dermatology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-10-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457776/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical, Cosmetic and Investigational Dermatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/CCID.S473224\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical, Cosmetic and Investigational Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/CCID.S473224","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"DERMATOLOGY","Score":null,"Total":0}
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.
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.
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.
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