Health Condition 1: null- Alopecia
Conditions
Interventions
Intervention1: Hairsteticsâ?? Hair Implant: HAIR IMPLANT ANCHORS AND SYSTEMS
Control Intervention1: Not Applicable: Not Applicable
Control Intervention2: Not Applicable: Not Applicable
Sponsors
Hairstetics Ltd
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint - Safety: For all subjects: Acceptable number, duration and severity of Expected Adverse Device/Procedure Effects during 3 months following implantation. Timepoint: 3 months following implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) For Sub-group B (subjects that their hair loss CANNOT be scaled by Hamilton/Norwoods Basic Scale for men and Ludwig scale for women) Please refer brief summary for details regarding Secondary Outcome.Timepoint: at 3 months and at 6 months post procedure. | — |
Countries
Belgium, France, India, Romania, United Kingdom
Contacts
Public ContactDr Shariq Anwar
Medical Monitor, Max Neeman International
Outcome results
None listed