Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected with Hair Loss- A Clinical Study - HET-03

Hairstetics Ltd0 个研究点目标入组 36 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 Hairsteticsâ?? Hair Implant) and has chosen to undergo synthetic hair implantation.
•If the subject does have hair in the scalp, it should be with a color that fits the color of the implant fiber.
•Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
•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.
•Subject has Good general health with no chronic diseases.
•Woman of child bearing potential must have a negative pregnancy test.
•Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.

•Previous synthetic hair implantation (apart from Hairsteticsâ?? Hair Implant) or hair transplantation.
•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.
•Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
•Currently using steroid product with Immunosuppressive treatment.
•Impaired coagulation.
•Serious illness that may affect subject compliance to protocol.
•Subject is using illegal drugs.
•Participating in other clinical study.
•Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
•For woman: Pregnancy or breast feeding.

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