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<p>Hydroquinone (HYD) is considered the gold standard topical therapy for melasma; however, the common occurrence of adverse effects limits its use. In this context, cysteamine (CYS) has emerged as a potential alternative agent for melasma treatment. A systematic review and meta-analysis was performed to compare the efficacy and safety of 5% cysteamine and 4% hydroquinone in patients diagnosed with facial melasma. Following PRISMA guidelines, PubMed, Embase, Cochrane Central and Web of Science databases were analyzed. Eligible studies were selected based on specific inclusion criteria, and data were independently extracted. The primary endpoint was change in the modified melasma area and severity index (mMASI), while the secondary endpoint was the occurrence of adverse effects, including erythema, burning, and itching. Statistical analysis was performed using R<sup>®</sup> version 4.4.2. Heterogeneity was assessed with I<sup>2</sup> statistics. A total of five randomized clinical trials were included in this analysis, encompassing 193 patients, 97 (50.26%) of whom received CYS. The reduction in mMASI score did not show a statistically significant difference between the 2 groups (37 CYS vs. 39 HYD; OR 0.90; 95% CI 0.50–1.62; <i>p</i> &gt; 0.05; I<sup>2</sup> = 0%), nor was the presence of adverse effects like erythema (25 CYS vs. 33 HYD; OR 0.68; 95% CI 0.36–1.30; <i>p</i> &gt; 0.05; I<sup>2</sup> = 0%), burning (17 CYS vs. 20 HYD; OR 0.81; 95% CI 0.39–1.70; <i>p</i> &gt; 0.05; I<sup>2</sup> = 0%) and itching (26 CYS vs. 33 HYD; OR 0.72; 95% CI 0.38–1.36; <i>p</i> &gt; 0.05; I<sup>2</sup> = 0%). This integrated analysis demonstrates that CYS is comparable to HYD in managing facial melasma, yielding equivalent improvement in skin pigmentation, with a similar side effect profile in the short term. However, these findings underscore the need for further investigation, given limitations such as small sample sizes and short follow-up periods, ideally through studies that employ standardized protocols and larger patient populations to confirm long-term outcomes and firmly establish the therapeutic role of CYS. Ultimately, this work lays a solid foundation for future research aimed at refining and optimizing clinical strategies for facial melasma management.</p>

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Comparative efficacy and safety of cysteamine and hydroquinone in the treatment of facial melasma: a systematic review and meta-analysis of randomized clinical trials

  • 期刊论文

  • 发表日期：

    2026年3月21日

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  • Gabriele Sevilhano Milanesi,
  • Ariane Barros Mesquita Cunha,
  • Anderson Matheus Pereira da Silva,
  • Melina Bafume,
  • Gabriela Cesar de Barros Abrantes,
  • Leonardo Galvão de Oliveira Oldra,
  • Axel Ravanello,
  • Lara Vitória Araújo de Oliveira,
  • Eryvelton de Souza Franco,
  • Leticia Vidotti Storti,
  • Renata Prota Hussein Skov,
  • Thais Prota Hussein Pincelli

摘要

Hydroquinone (HYD) is considered the gold standard topical therapy for melasma; however, the common occurrence of adverse effects limits its use. In this context, cysteamine (CYS) has emerged as a potential alternative agent for melasma treatment. A systematic review and meta-analysis was performed to compare the efficacy and safety of 5% cysteamine and 4% hydroquinone in patients diagnosed with facial melasma. Following PRISMA guidelines, PubMed, Embase, Cochrane Central and Web of Science databases were analyzed. Eligible studies were selected based on specific inclusion criteria, and data were independently extracted. The primary endpoint was change in the modified melasma area and severity index (mMASI), while the secondary endpoint was the occurrence of adverse effects, including erythema, burning, and itching. Statistical analysis was performed using R® version 4.4.2. Heterogeneity was assessed with I2 statistics. A total of five randomized clinical trials were included in this analysis, encompassing 193 patients, 97 (50.26%) of whom received CYS. The reduction in mMASI score did not show a statistically significant difference between the 2 groups (37 CYS vs. 39 HYD; OR 0.90; 95% CI 0.50–1.62; p > 0.05; I2 = 0%), nor was the presence of adverse effects like erythema (25 CYS vs. 33 HYD; OR 0.68; 95% CI 0.36–1.30; p > 0.05; I2 = 0%), burning (17 CYS vs. 20 HYD; OR 0.81; 95% CI 0.39–1.70; p > 0.05; I2 = 0%) and itching (26 CYS vs. 33 HYD; OR 0.72; 95% CI 0.38–1.36; p > 0.05; I2 = 0%). This integrated analysis demonstrates that CYS is comparable to HYD in managing facial melasma, yielding equivalent improvement in skin pigmentation, with a similar side effect profile in the short term. However, these findings underscore the need for further investigation, given limitations such as small sample sizes and short follow-up periods, ideally through studies that employ standardized protocols and larger patient populations to confirm long-term outcomes and firmly establish the therapeutic role of CYS. Ultimately, this work lays a solid foundation for future research aimed at refining and optimizing clinical strategies for facial melasma management.