CTRI/2017/05/008472尚未招募未知
Prospective Safety and Efficacy Evaluation of Hairsteticsâ?¢ Anchoring System for Hair Extensions in Female Pattern Hair Loss. - HAS-FPH
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age greater than equal to 19 yrs.
- •2.Female patients with androgenetic alopecia (FPHL).
- •3.Pre-treatment hematology and coagulation values within the limits:
- •a.Hemoglobin >= 10 g/dl (g/100 ml)
- •b.Platelets >= 150 x 109/L (103/mm3)
- •c. WBC >= 3.0 x 109/L (103/mm3)
- •d.INR 0.8 - 1.2
- •e. PTT25â?? - 35â??
- •f.Serum creatinine < 2 mg/dl
- •g.SGOT < 1.5 x ULN (Upper Limit of Norm)
- •h.SGPT < 1.5 x ULN
- •i.Alkaline phosphatase < 1.5 x ULN
- •4.A life expectancy at least of the duration of the trial.
- •Signed informed consent and post-implantation protocol.
排除标准
- •1.Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study.
- •2.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.
- •3.Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy.
- •4.Patients on anticoagulant treatment.
- •5.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 â??corticosteroid treatment) or patients with an immunocompromised state for any reason.
- •6.Bleeding disorder.
- •7.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.
- •8.Use of illegal substances.
- •9.Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsorâ??s authorized representative.
- •10.Quantitative Beta-HCG greater than equal to 5 mIU/mL (IU/L) in women of childbearing potential.
- •11.Lactating and/or breastfeeding women.
- •12.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.
- •13.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.
研究者
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