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Abstract：
BACKGROUND: The aim of this study was to assess the efficacy and safety of 15% azelaic acid (AzA) gel in treating acne-induced post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH). The effects of 15% AzA gel on acne, skin barrier function, and quality of life were also evaluated.
METHODS: A total of 72 patients with mild to moderate acne were enrolled in a randomized, double-blind, placebo-controlled trial. Patients were divided into two groups: patients in the AzA group applied 15% AzA gel twice daily for 12 weeks, and those in the placebo group applied AzA-free gel. Clinical evaluations using non-invasive skin detection technologies, including VISIA skin analysis, dermoscopy, and skin physiological function tests, were performed at 0, 4, 8, and 12 weeks. Main outcome measures included the post-acne hyperpigmentation index (PAHPI), melanin, hemoglobin, individual typology angle, water content, transepidermal water loss, and sebum. Investigator Global Assessment) and Dermatology Life Quality Index (DLQI) assessments were conducted at weeks 0 and 12. Adverse reactions were recorded.
RESULTS: Of the 72 patients at study initiation, 60 completed the trial. At 8 and 12 weeks, patients in the AzA group showed significantly reduced PAHPI for PIE lesions compared to baseline and patients receiving placebo (P < 0.05). Patients in both groups exhibited reduced PIH lesions at weeks 8 and 12 that differed significantly from baseline (P < 0.05). Hemoglobin content decreased significantly in AzA-treated PIE lesions compared to those treated with placebo at week 12 (P < 0.05). Melanin content decreased significantly in AzA-treated PIH lesions at week 12 (P < 0.05). The AzA group showed higher improvement in DLQI (P < 0.05), and greater overall satisfaction (P < 0.05) compared to placebo.
CONCLUSIONS: The results indicate that 15% AzA gel effectively improved acne-induced PIE and PIH with minimal adverse reactions, making it a viable clinical application. In the study population, it had no adverse effects on skin barrier function and contributed positively to acne improvement and patient quality of life.
BACKGROUND: This study was registered with the Chinese Clinical Trial Registry (ChiCTR.org.cn) under the identifier ChiCTR2300076959. The registration date was 25 October 2023, retrospectively registered.
METHODS: A total of 72 patients with mild to moderate acne were enrolled in a randomized, double-blind, placebo-controlled trial. Patients were divided into two groups: patients in the AzA group applied 15% AzA gel twice daily for 12 weeks, and those in the placebo group applied AzA-free gel. Clinical evaluations using non-invasive skin detection technologies, including VISIA skin analysis, dermoscopy, and skin physiological function tests, were performed at 0, 4, 8, and 12 weeks. Main outcome measures included the post-acne hyperpigmentation index (PAHPI), melanin, hemoglobin, individual typology angle, water content, transepidermal water loss, and sebum. Investigator Global Assessment) and Dermatology Life Quality Index (DLQI) assessments were conducted at weeks 0 and 12. Adverse reactions were recorded.
RESULTS: Of the 72 patients at study initiation, 60 completed the trial. At 8 and 12 weeks, patients in the AzA group showed significantly reduced PAHPI for PIE lesions compared to baseline and patients receiving placebo (P < 0.05). Patients in both groups exhibited reduced PIH lesions at weeks 8 and 12 that differed significantly from baseline (P < 0.05). Hemoglobin content decreased significantly in AzA-treated PIE lesions compared to those treated with placebo at week 12 (P < 0.05). Melanin content decreased significantly in AzA-treated PIH lesions at week 12 (P < 0.05). The AzA group showed higher improvement in DLQI (P < 0.05), and greater overall satisfaction (P < 0.05) compared to placebo.
CONCLUSIONS: The results indicate that 15% AzA gel effectively improved acne-induced PIE and PIH with minimal adverse reactions, making it a viable clinical application. In the study population, it had no adverse effects on skin barrier function and contributed positively to acne improvement and patient quality of life.
BACKGROUND: This study was registered with the Chinese Clinical Trial Registry (ChiCTR.org.cn) under the identifier ChiCTR2300076959. The registration date was 25 October 2023, retrospectively registered.
摘要：
背景：本研究的目的是评估15%壬二酸（AzA）凝胶治疗痤疮诱发的炎症后红斑（PIE）和炎症后色素沉着过度（PIH）的疗效和安全性。15%AzA凝胶对痤疮的影响，皮肤屏障功能，和生活质量也进行了评估。
方法：共纳入72例轻度至中度痤疮患者，双盲,安慰剂对照试验。患者分为两组：AzA组患者每天两次使用15％AzA凝胶，持续12周，安慰剂组应用无AzA凝胶。使用非侵入性皮肤检测技术进行临床评估，包括VISIA皮肤分析，皮肤镜,和皮肤生理功能测试，在0、4、8和12周进行。主要结局指标包括痤疮后色素沉着指数（PAHPI），黑色素,血红蛋白,个体类型学角度，含水量,经皮水分流失，还有皮脂.研究者全球评估）和皮肤病生活质量指数（DLQI）评估在第0周和第12周进行。记录不良反应。
结果：在研究开始的72名患者中，60人完成了审判。在8周和12周，与基线和接受安慰剂的患者相比,AzA组患者PIE病变的PAHPI显著降低(P<0.05).两组患者在第8周和第12周表现出减少的PIH病变，与基线有显著差异（P<0.05）。在第12周，与安慰剂治疗的PIE病变相比，AzA治疗的PIE病变的血红蛋白含量显着降低（P<0.05）。在12周时，AzA治疗的PIH病变中黑色素含量显着降低（P<0.05）。AzA组的DLQI改善明显(P<0.05),与安慰剂相比，总体满意度更高（P<0.05）。
结论：结果表明，15％AzA凝胶可有效改善痤疮引起的PIE和PIH，不良反应最小，使其成为一个可行的临床应用。在研究人群中，对皮肤屏障功能无不良影响,对痤疮改善和患者生活质量有积极作用.
背景：本研究已在中国临床试验注册中心（ChiCTR.org。cn)在标识符ChiCTR2300076959下。注册日期为2023年10月25日，追溯注册。
方法：共纳入72例轻度至中度痤疮患者，双盲,安慰剂对照试验。患者分为两组：AzA组患者每天两次使用15％AzA凝胶，持续12周，安慰剂组应用无AzA凝胶。使用非侵入性皮肤检测技术进行临床评估，包括VISIA皮肤分析，皮肤镜,和皮肤生理功能测试，在0、4、8和12周进行。主要结局指标包括痤疮后色素沉着指数（PAHPI），黑色素,血红蛋白,个体类型学角度，含水量,经皮水分流失，还有皮脂.研究者全球评估）和皮肤病生活质量指数（DLQI）评估在第0周和第12周进行。记录不良反应。
结果：在研究开始的72名患者中，60人完成了审判。在8周和12周，与基线和接受安慰剂的患者相比,AzA组患者PIE病变的PAHPI显著降低(P<0.05).两组患者在第8周和第12周表现出减少的PIH病变，与基线有显著差异（P<0.05）。在第12周，与安慰剂治疗的PIE病变相比，AzA治疗的PIE病变的血红蛋白含量显着降低（P<0.05）。在12周时，AzA治疗的PIH病变中黑色素含量显着降低（P<0.05）。AzA组的DLQI改善明显(P<0.05),与安慰剂相比，总体满意度更高（P<0.05）。
结论：结果表明，15％AzA凝胶可有效改善痤疮引起的PIE和PIH，不良反应最小，使其成为一个可行的临床应用。在研究人群中，对皮肤屏障功能无不良影响,对痤疮改善和患者生活质量有积极作用.
背景：本研究已在中国临床试验注册中心（ChiCTR.org。cn)在标识符ChiCTR2300076959下。注册日期为2023年10月25日，追溯注册。
