Singal Amit, Vijayvargiya Nina, Pathak Naeha, Lipner Shari R
Rutgers New Jersey Medical School, Newark, NJ, USA.
Department of Dermatology, Weill Cornell Medicine, New York, NY, USA.
Skin Appendage Disord. 2025 Jun;11(3):232-244. doi: 10.1159/000542568. Epub 2024 Nov 12.
Nail involvement occurs in approximately 90% of patients with cutaneous psoriasis and in isolation in 5%-10% of patients. There is an unmet need for diagnostic and therapeutic algorithms for nail psoriasis (NP), partially due to limited number of clinical trials.
The ClinicalTrials.gov, the EU, the Australian New Zealand, and the World Health Organization International Clinical Trials Registries were queried for the term "nail psoriasis". Trial data characteristics were collected and analyzed.
A total of 112 clinical trials were included, with mean trial length 46.7 weeks and mean number of participants 272.7. Medications were most often studied in 97 (86.6%) trials, followed by lasers in 7 (6.3%) trials. NP Severity Index score was the most often studied outcome measure in 91 (84.3%) trials, and only 56 (52.8%) trials assessed adverse events. Only 3 (2.83%) trials included children, and many clinical trials excluded patients aged 65+ and 85+. Results were posted for 46 (41.4%) trials with mean participant age 45.1 years, mean percentage of females of 38.3%, and 87.8% of participants being White.
Our findings highlight a need for clinical trials assessing efficacy and long-term therapeutic safety with a broad range of age-groups and increased representation of minorities and female patients.
约90%的皮肤银屑病患者会出现指甲受累情况，5%-10%的患者仅表现为指甲病变。由于临床试验数量有限，目前对于指甲银屑病（NP）的诊断和治疗方案仍存在需求缺口。
在ClinicalTrials.gov、欧盟、澳大利亚和新西兰以及世界卫生组织国际临床试验注册库中查询“指甲银屑病”一词。收集并分析试验数据特征。
共纳入112项临床试验，平均试验时长为46.7周，平均参与人数为272.7人。97项（86.6%）试验主要研究药物，7项（6.3%）试验研究激光。91项（84.3%）试验最常研究的结局指标是NP严重程度指数评分，仅有56项（52.8%）试验评估了不良事件。仅3项（2.83%）试验纳入了儿童，许多临床试验排除了65岁及以上和85岁及以上的患者。46项（41.4%）试验公布了结果，参与试验者的平均年龄为45.1岁，女性平均占比为38.3%，87.8%的参与者为白人。
我们的研究结果表明，需要开展临床试验来评估不同年龄组的疗效和长期治疗安全性，并增加少数族裔和女性患者的代表性。
