Hairsteticsâ?¢ Anchoring System and Hair Extensions with female hair loss

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

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 0.8 - 1.2

e. PTT25â?? - 35â??

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.

Exclusion Criteria

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 â??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 Sponsorâ??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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide evidence of safety and preliminary performance of the Hairsteticsâ?¢ anchoring system in female subjects affected with androgenetic alopecia (FPHL).Timepoint: At the 6-month follow up

Secondary Outcome Measures

Name	Time	Method
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.Timepoint: At the 6-month follow up