NCT04941807已完成4 期
Use of Platelet-rich Plasma (PRP) Therapy in Patients With Brittle Nail Syndrome
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Physician Global Improvement Assessment (PGIA)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of platelet-rich plasma therapy for brittle nail syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Treatment is open-label with respect to patient and investigators but is blinded to an endpoint committee.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with brittle nails
- •Must understand and voluntarily sign an informed consent form
- •Must be male or female and aged 18-95 years at time of consent
- •Must be able to adhere to the study visit schedule and other protocol requirements
- •A nail clipping with histopathology that is negative for the presence of dermatophyte infection
- •Patient must present with at least a score of 2 on the PGA scale.
排除标准
- •Inability of the patient to provide written informed consent for any reason.
- •Subject has psoriasis, lichen planus, dermatophyte infection or other confounding abnormalities that are severe enough to result in a clinically abnormal fingernail
- •Use of any medication within 90 days prior to start of study
- •Inability to abstain for nail polishes, nail gels during the study period
- •Subject is pregnant or planning pregnancy.
结局指标
主要结局
Physician Global Improvement Assessment (PGIA)
时间窗: At 16 weeks
The PGIA will be based on a comparison of photographs taken at baseline to the nails at week 16 of follow-up. The Physician Global Improvement Score (PGIA) evaluates the improvement of lamellar splitting, transverse splitting, ridges, longitudinal grooves, longitudinal splitting, and nail thickness in target fingernails. Change is classified as excellent, good, or fair, or categorized as no improvement or worsening.
次要结局
- Change From Baseline in Qualify of Life, as Measured by the Modified Nail Psoriasis Quality of Life Scale (NPQ10) Between Baseline and Week 16(Subjective assessments of quality of life impact due to nail health will be collected at baseline and week 16)
研究者
研究点 (1)
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