Abstract：
BACKGROUND: Dyschromia can be associated with increased production and/or reduced clearance of pigmentation in the skin. Multiple pathways are involved in causality. A novel topical product was recently developed, which contains actives that have been validated through in-vitro and clinical studies to counteract pigmentation related to photodamage, PIH, and melasma. This study further evaluates the safety and efficacy of this product for facial dyschromia during an additional 3-month extension period following the completion of the previous 12-week multi-center trial. Study Design: Subjects from the previous multi-center trial with mild to severe facial dyschromia at baseline were eligible to participate in this 3-month extension study upon completion of that trial. This extension study evaluated the continued use of the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) over a 3-month period. Subjects who were previously randomized to the novel topical product continued using it and for those previously randomized to hydroquinone 4% discontinued its use. Both cohorts continued daily sunscreen use. Blinded investigators assessed subjects at follow-up visits at 16, 20, and 24 weeks.
RESULTS: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort. Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement. J Drugs Dermatol. 2024;23(1):1266-1270. doi:10.36849/JDD.7622.
RESULTS: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort. Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement. J Drugs Dermatol. 2024;23(1):1266-1270. doi:10.36849/JDD.7622.
摘要：
背景：色素沉着可能与皮肤中色素沉着的产生增加和/或清除减少有关。因果关系涉及多种途径。最近开发了一种新颖的局部产品，其中包含通过体外和临床研究验证的活性物质，以抵消与光损伤相关的色素沉着，PIH,还有黄褐斑.这项研究进一步评估了该产品在完成前12周多中心试验后的3个月延长期内对面部色素异常的安全性和有效性。研究设计:先前多中心试验的受试者在基线时具有轻度至重度面部色素异常,在完成该试验后,有资格参与这项为期3个月的延长研究。这项扩展研究评估了PATH-3技术（Alastin护肤，卡尔斯巴德,CA)在3个月内。先前被随机分配到新型外用产品的受试者继续使用它，而先前被随机分配到氢醌4％的受试者则停止使用它。两个队列都继续每天使用防晒霜。失明的研究人员在16、20和24周的随访中评估了受试者。
结果：二十六（26）名受试者完成了关键试验的延伸阶段，在AL和HQ-BREAK队列中每个队列中有13名受试者。在12至24周的AL队列中，面部色素异常（P=0.0158）和肤色/清晰度/均匀度（P=0.0067）均有显着改善，而HQ-BREAK队列没有显著改善.HQ-BREAK队列中有更多的受试者因面部色素异常和肤色/清晰度/均匀度而恶化。对于mMASI来说，与第12周相比,HQ-BREAK队列在第24周表现出消退,而AL队列反而持续改善.发现这种差异是显著的(P=0.02)。任一队列均未报告与研究相关的不良事件。结论：已证明使用PATH-3技术设计用于抵消色素沉着途径中各种步骤的新型外用产品可长期安全有效地治疗面部色素失调。与总部受试者经历的明显反弹相反，AL队列继续显示持续改善.J药物Dermatol.2024；23（1）：1266–1270。doi:10.36849/JD.7622。
结果：二十六（26）名受试者完成了关键试验的延伸阶段，在AL和HQ-BREAK队列中每个队列中有13名受试者。在12至24周的AL队列中，面部色素异常（P=0.0158）和肤色/清晰度/均匀度（P=0.0067）均有显着改善，而HQ-BREAK队列没有显著改善.HQ-BREAK队列中有更多的受试者因面部色素异常和肤色/清晰度/均匀度而恶化。对于mMASI来说，与第12周相比,HQ-BREAK队列在第24周表现出消退,而AL队列反而持续改善.发现这种差异是显著的(P=0.02)。任一队列均未报告与研究相关的不良事件。结论：已证明使用PATH-3技术设计用于抵消色素沉着途径中各种步骤的新型外用产品可长期安全有效地治疗面部色素失调。与总部受试者经历的明显反弹相反，AL队列继续显示持续改善.J药物Dermatol.2024；23（1）：1266–1270。doi:10.36849/JD.7622。
