Thielitz A, Lux A, Wiede A, Kropf S, Papakonstantinou E, Gollnick H
Department of Dermatology and Venereology, Otto-von-Guericke University, Magdeburg, Germany.
J Eur Acad Dermatol Venereol. 2015 Apr;29(4):789-96. doi: 10.1111/jdv.12823. Epub 2014 Nov 14.
Growing numbers of post-adolescent females are suffering from treatment-resistant or relapsing adult acne forms, therefore requiring the definition of safe and effective treatment options for this burdening disease.
To assess the efficacy of azelaic acid 15% gel (AzA) vs. no treatment during maintenance therapy of female adult acne and to compare its efficacy and safety vs. adapalene 0.1% gel (AD) during a 9-month period (3-month treatment and 6-month maintenance treatment).
A total of 55 women between 18 and 45 years with adult acne were included in this investigator-blind trial and randomized into three groups receiving AzA gel b.i.d. for 9 months (AzA9M, n = 17) or AzA gel b.i.d. for 3 months followed by a 6-month observational phase (AzA3M, n = 19) or AD gel once daily for 9 months (AD9M, n = 19). Parameters of efficacy, safety and patient-related factors were analysed.
The reduction in lesion counts, severity and Dermatology Life Quality Index score was significant (P < 0.05) and comparable between groups during the treatment phase, while dryness and scaling were significantly lower (P < 0.05) in group AzA9M vs. AD9M. During maintenance, AzA9M was superior to AzA3M in the control of inflammatory lesions (P = 0.008) and total lesions (P = 0.014) at week 24. From week 12 to week 36, a mild relative increase in inflammatory lesions could be observed in all groups. In AzA3M, this increase exceeded that of AzA9M by 23.1% (P = 0.109), while the difference of total lesions diverged to 30.8% (P = 0.038). No significant differences could be detected between AzA9M and AD9M. Group AzA9M was non-inferior to AD9M (non-inferiority margin of 50% for the confidence limit for the relative effect) in the control of inflammatory acne lesions.
AzA15% gel is a safe and effective treatment and maintenance treatment of female adult acne with non-inferior efficacy to AD 0.1% gel in the control of inflammatory acne.
越来越多的青春期后女性患有难治性或复发性成人痤疮，因此需要为这种负担沉重的疾病确定安全有效的治疗方案。
评估15%壬二酸凝胶（AzA）与不治疗相比在女性成人痤疮维持治疗中的疗效，并在9个月期间（3个月治疗期和6个月维持治疗期）比较其与0.1%阿达帕林凝胶（AD）的疗效和安全性。
本研究者盲法试验共纳入55名18至45岁的成人痤疮女性，随机分为三组，分别接受AzA凝胶每日两次，共9个月（AzA9M组，n = 17），或AzA凝胶每日两次，共3个月，随后进入6个月观察期（AzA3M组，n = 19），或AD凝胶每日一次，共9个月（AD9M组，n = 19）。分析疗效、安全性和患者相关因素参数。
在治疗阶段，各组的皮损计数、严重程度和皮肤病生活质量指数评分均显著降低（P < 0.05）且具有可比性，而AzA9M组的干燥和脱屑情况显著低于AD9M组（P < 0.05）。在维持期，AzA9M组在第24周时在控制炎性皮损（P = 0.008）和总皮损（P = 0.014）方面优于AzA3M组。从第12周到第36周，所有组均观察到炎性皮损有轻度相对增加。在AzA3M组，这种增加比AzA9M组高出23.1%（P = 0.109），而总皮损的差异为30.8%（P = 0.038）。AzA9M组和AD9M组之间未检测到显著差异。AzA9M组在控制炎性痤疮皮损方面不劣于AD9M组（相对效应置信限的非劣效界值为50%）。
15%AzA凝胶是女性成人痤疮安全有效的治疗和维持治疗方法，在控制炎性痤疮方面疗效不劣于0.1%AD凝胶。
