NCT02316418Unknown不适用
Prospective Safety and Efficacy Evaluation of Hairstetics™ Anchoring System for Hair Extensions in Female Pattern Hair Loss
Hairstetics2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percent of subjects with at least 70% of the hair extensions
研究概览
简要总结
The aim of the study is to provide evidence of safety and preliminary performance of the Hairstetics™ anchoring system in female subjects affected with androgenetic alopecia (female pattern hair loss; (FPHL)).
The study will also help to determine whether the Hairstetics™ anchoring system, in conjunction with attachment of hair extensions, is efficacious in improving patient and physician aesthetic satisfaction with the treated scalp appearance in female patients with androgenetic alopecia.
详细描述
- Type of trial: Open label
- Study population: Female patients with androgenetic alopecia (FPHL)
- Phase: II
- Number of study arms: Single-arm
- Number of centers: Single center
- Name of study agent: Hairstetics™ hair anchoring system
- Changes in scheduling: maximal number of implants may not be modified throughout the trial.
ENDPOINTS
Primary Endpoint:
Percent of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit.
Secondary Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 19 yrs.
- •Female patients with androgenetic alopecia (FPHL).
- •Pre-treatment hematology and coagulation values within the limits:
- •Hemoglobin ≥ 10 g/dl (g/100 ml)
- •Platelets ≥ 150 x 10^9/L (10^3/mm^3)
- •WBC ≥ 3.0 x 10^9/L (10^3/mm^3)
- •INR 0.8 - 1.2 ---
- •PTT 25" - 35"
- •Serum creatinine < 2 mg/dl
- •SGOT < 1.5 x ULN (Upper Limit of Norm)
- •SGPT < 1.5 x ULN
- •Alkaline phosphatase < 1.5 x ULN
- •A life expectancy at least of the duration of the trial.
- •Signed informed consent and post-implantation protocol.
排除标准
- •Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study.
- •Skin conditions that might affect the procedure and/or its outcome. NOTE: Such conditions are not necessarily restricted to or involve the prospective implantation site and/or its vicinity.
- •Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy.
- •Patients on anticoagulant treatment.
- •More than a maintenance dose of oral corticosteroids (maintenance dose is defined as the same dose regimen over the past 6 months for a condition requiring continual corticosteroid treatment) or patients with an immunocompromised state for any reason.
- •Bleeding disorder.
- •Patient presenting with a health condition that may affect compliance with the study protocol, either by itself or combined with other conditions present in the patient.
- •Use of illegal substances.
- •Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative.
- •Quantitative β-HCG ≥ 5 mIU/mL (IU/L) in women of childbearing potential.
- •Lactating and/or breastfeeding women.
- •Known hypersensitivity (e.g., to nitinol, nickel or titanium) or adverse event that would prevent a prospective study participant from being administered the trial treatment or non-investigational medicinal product(s), as detailed in the protocol.
- •Patients with implanted electronic devices (such as cardiac pacemakers) unless they receive permission from their treating physician (e.g., cardiologist) and are monitored by a treating physician during the treatment session.
结局指标
主要结局
Percent of subjects with at least 70% of the hair extensions
时间窗: 6 months after attachment of hair extensions
Percent of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit.
次要结局
- Investigator aesthetic satisfaction(at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment)
- Proportion of hair extensions remaining at place at the different visits.(from attachment of hair extensions through study completion, an average of 6 months)
- Pain rating during procedure(At implantation)
- Subject aesthetic satisfaction(at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment)
研究者
研究点 (2)
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