This is a single-center, prospective, single-arm study for female subjects affected with androgenetic alopecia (FPHL).

The study will consist of three periods: 1) Screening; 2) Implantation treatment and attachment of hair extensions; and 3) Follow-up.

Screening period

After signing informed consent, patients will be screened for study eligibility by assessment of inclusion and exclusion criteria.  Screening procedures will include collection of demographic data, medical history, physical examination, vital signs, and laboratory evaluations.  

Implantation Period

For subject data to be evaluable, implantation is to be performed.

Subjects will be implanted with Hairsteticsâ„¢ anchoring system cartridges holding up to a total of 360 of the Hairsteticsâ„¢ prosthetic hair units.  Complete blood count (CBC), biochemistry and coagulation panel and a quantitative β-HCG, as specified in the eligibility criteria, will be required before treatment and the test requirements specified in the inclusion criteria must be met. Implantation will be carried out unless the patient’s participation in the trial is terminated due to one of the following:

·         non-study treatment in or within 3 cm of the area implanted with the study prosthetic hair;

·         occurrence of a serious adverse event which necessitates a change in treatment;

·         withdrawal of consent;

·         Investigator’s decision;

·         malignancies and/or other health conditions that require treatment that might affect the procedure and/or its outcome;

·         significant protocol deviation/violation or noncompliance, either on the part of the subject or Investigator;

·         device failure;

·         other ethical or clinical considerations at the discretion of Investigator;

·         subject lost to follow-up;

·         subject refusal to continue follow-up;

Patients will be followed a week after the study implantation procedure, to ensure proper monitoring of safety events.

Hair extensions will be attached four weeks after the implantation.

Follow-up

Patients will be followed at 3 and 6 months after the attachment of hair extensions.

This protocol will allow excision of implants. The following considerations for implant(s) retrieval will apply in this study:

Implants removed in a revision intervention following a safety event, if deemed necessary by the Investigator, or if requested by the subject are referred to as retrievals.

Retrieval analyses:

Retrievals will be collected by the respective site Investigator and;

a.     number of prosthetic fibers retrieved will be comprehensively documented by the Investigator;

b.     further, the Investigator will record the number of prosthetic fibers excised with their bulb and with or without the anchor,

c.     retrieval assessment will be documented;