jRCTs032220402暂停不适用
Hair Regrowth Effect of Non-contact Focused Ultrasound Irradiation in Patients with Female Pattern Alopecia
未提供0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 主要终点
- Phototrichogram evaluation of the test site at 12 and 24 weeks (percentage of growing hairs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 50age old not（—）
- 性别
- Female
入选标准
- •Japanese female subjects who are between 20 and 50 years of age at the time of obtaining written conse
- •nt to participate in the study and who have an understanding of the study
- •have FPHL (Savin classification: II-III, Advanced)
- •who are able to shave the evaluation site and come to the clinic for the procedure
- •who can come to the hospital on the designated examination and treatment days and undergo the examination
- •who are basically engaged in indoor work
- •who have explained about the study using the consent document and obtained consent
排除标准
- •those with anemia, thyroid disease, collagen disease, polycystic ovaries, hyperprolactinemia, or other conditions that cause symptoms of hair loss
- •those who consume excessive amounts of alcohol
- •those whose lifestyle may change during the examination period (e.g., working at night, traveling for long periods of time)
- •who have participated in other clinical trials or clinical studies from the past 6 months to the present
- •who are currently undergoing treatment for FPHL (medication, hair transplantation, etc.)
- •who have been determined to have alopecia due to postpartum
- •who have used drugs such as RiUP for the treatment of female pattern baldness within the past 3 months
- •those who have skin conditions such as skin allergies, atopic dermatitis, seborrheic dermatitis, etc. on the scalp
- •Women who are pregnant or may become pregnant, or who wish to become pregnant during the study period
- •any other person whom the principal investigator or subinvestigator determines to be inappropriate to participate in this study.
结局指标
主要结局
Phototrichogram evaluation of the test site at 12 and 24 weeks (percentage of growing hairs)
时间窗: 12 and 24 weeks
The growth phase hair percentage was calculated by determining the number of growth phase hairs immediately after shaving and 3 days later within a shaved area of 2 cm in diameter.
次要结局
- Hair density(Weeks 12 and 24)
- Hair diameter(Weeks 12 and 24)
- Hair elongation(Weeks 12 and 24)
- Neurological symptoms
研究者
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