Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected with Hair Loss- A Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Primary Endpoint - Safety:
研究概览
简要总结
This isa prospective, single-arm (with two Sub-groups), multi-center, international,open-label, non-randomized, clinical study to evaluate the safety and efficacyof Hairstetics’ Hair Implant in subject affected with hair loss. The study will enroll 36 subjects globallyfrom 8 centers in total from India, UK, Belgium, France and Romania.
Therecruitment period for the study in India is 3 months.
The primary endpoint ofthis study is safety of all subjects, Acceptable number, duration and severityof Expected Adverse Device/Procedure Effects during 3 months followingimplantation.
The secondary endpoint of this study is Efficacy and Safety
ForSub-group A (subjects that their hair loss CAN be scaled by Hamilton/Norwood’sBasic Scale for men and Ludwig scale for women)
o 6 months efficacy determined by alopecia scales (by theinvestigator) in the treated areas. Efficacy will be considered successful ifless than 30% of the subjects will return to their baseline alopecia level at 6months follow-up, in the treated areas. Once the study will convert to a postmarketing one, after the initial 6 subjects, this secondary endpoint willbecome a primary efficacy endpoint.
o Subject’s satisfaction with the procedure outcome, at 3 months andat 6 months post procedure.
o Implanted fiber durability (fiber breakage, curling etc. to bedefined as negligible, minor, mild, moderate and significant) at 6 months postprocedure by the investigator.
o Annual fiber fall rate based on hair count at pre-definedlocations at 3 and 6 months post procedure. If “hair count†cartridges will be implanted in the test implantation(see elsewhere), their fibers will be followed-up at the actual implantationvisit and the 6 weeks visit post the actual implantation as well.
o Acceptable number, duration and severity of Expected AdverseDevice/Procedure Effects at 6 months following implantation.
ForSub-group B (subjects that their hair loss CANNOT be scaled byHamilton/Norwood’s Basic Scale for men and Ludwig scale for women)
o Subject’s satisfaction with the procedure outcome, at 3 months andat 6 months post procedure. Once thestudy will convert to a post marketing one, after the initial 6 subjects, thissecondary endpoint will become a primary efficacy endpoint.
o Implanted fiber durability (fiber breakage, curling etc. to bedefined as negligible, minor, mild, moderate and significant) at 6 months postprocedure by the investigator.
o Annual fiber fall rate based on hair count by the investigator atpre-defined locations at 3 and 6 months post procedure. If “hair count†cartridges will be implantedin the test implantation (see elsewhere), their fibers will be followed-up atthe actual implantation visit and the 6 weeks visit post the actual implantationas well.
o Acceptablenumber, duration and severity of Expected Adverse Device/Procedure Effects at 6months following implantation.
After signing theInformed Consent Form the subject will undergo synthetic hair implantation. Thesubject will be followed up after 6 month for evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subject is ≥ 19 years old (male and female both) •Subject has hair loss and has never gone through a synthetic hair implantation (but allow subjects that were implanted in the past with Hairstetics’ Hair Implant) and has chosen to undergo synthetic hair implantation.
- •â€¢If the subject does have hair in the scalp, it should be with a color that fits the color of the implant fiber.
- •â€¢Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
- •â€¢Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
- •â€¢Subject has Good general health with no chronic diseases.
- •â€¢Woman of child bearing potential must have a negative pregnancy test.
- •â€¢Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.
排除标准
- •â€¢Previous synthetic hair implantation (apart from Hairstetics’ Hair Implant) or hair transplantation.
- •â€¢Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
- •â€¢Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
- •â€¢Currently using steroid product with Immunosuppressive treatment.
- •â€¢Impaired coagulation.
- •â€¢Serious illness that may affect subject compliance to protocol.
- •â€¢Subject is using illegal drugs.
- •â€¢Participating in other clinical study.
- •â€¢Known allergy or hypersensitivity to Nitinol or Nickel or Titanium •For woman: Pregnancy or breast feeding.
结局指标
主要结局
Primary Endpoint - Safety:
时间窗: 3 months following implantation
For all subjects:
时间窗: 3 months following implantation
Acceptable number, duration and severity of Expected Adverse Device/Procedure Effects during 3 months following implantation.
时间窗: 3 months following implantation
次要结局
- Secondary Endpoints - Efficacy and Safety:(For Sub-group A (subjects that their hair loss CAN be scaled by Hamilton/Norwoods Basic Scale for men and Ludwig scale for women))