Prospective Safety and Efficacy Evaluation of Hairsteticsâ„¢ Anchoring System for Hair Extensions in Female Pattern Hair Loss.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To provide evidence of safety and preliminary performance of the Hairsteticsâ„¢ anchoring system in female subjects affected with androgenetic alopecia (FPHL).
研究概览
简要总结
This is asingle-center, prospective, single-arm study for female subjects affected with androgeneticalopecia(FPHL).
The studywill consist of three periods: 1) Screening; 2) Implantation treatment andattachment of hair extensions; and 3) Follow-up.
Screeningperiod
Aftersigning informed consent, patients will be screened for study eligibility byassessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data,medical history, physical examination, vital signs, and laboratory evaluations.
ImplantationPeriod
For subject data to be evaluable, implantationis to be performed.
Subjects will beimplanted with Hairstetics™ anchoring system cartridges holding up to a totalof 360 of the Hairstetics™ prosthetic hair units. Complete blood count (CBC), biochemistry andcoagulation panel and a quantitative β-HCG, as specified in the eligibilitycriteria, will be required before treatment and the test requirements specifiedin the inclusion criteria must be met. Implantation will be carried out unlessthe patient’s participation in the trial is terminated due to one of thefollowing:
· non-study treatment in orwithin 3 cm of the area implanted with the study prosthetic hair;
· occurrence of a seriousadverse event which necessitates a change in treatment;
· withdrawal of consent;
· Investigator’s decision;
· malignancies and/or otherhealth conditions that require treatment that might affect the procedure and/orits outcome;
· significant protocoldeviation/violation or noncompliance, either on the part of the subject orInvestigator;
· device failure;
· other ethical or clinicalconsiderations at the discretion of Investigator;
· subject lost to follow-up;
· subject refusal to continuefollow-up;
Patients will be followed a week after thestudy implantation procedure, to ensure proper monitoring of safety events.
Hair extensions will be attached four weeksafter the implantation.
Follow-up
Patients will befollowed at 3 and 6 months after the attachment of hair extensions.
Thisprotocol will allow excision of implants. The following considerations forimplant(s) retrieval will apply in this study:
Implantsremoved in a revision intervention following a safety event, if deemednecessary by the Investigator, or if requested by the subject are referred toas retrievals.
Retrieval analyses:
Retrievalswill be collected by the respective site Investigator and;
a. numberof prosthetic fibers retrieved will be comprehensively documented by theInvestigator;
b. further,the Investigator will record the number of prosthetic fibers excised with theirbulb and with or without the anchor,
c. retrievalassessment will be documented;
This protocol does not provide arrangements forlong-term follow-up of study participants beyond primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
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.
- •1.2 e. PTT25â€.
- •35†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 ‎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 Sponsor’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.
结局指标
主要结局
To provide evidence of safety and preliminary performance of the Hairsteticsâ„¢ anchoring system in female subjects affected with androgenetic alopecia (FPHL).
时间窗: At the 6-month follow up
次要结局
- To determine whether the Hairsteticsâ„¢ 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.(At the 6-month follow up)