None listed
Conditions
Interventions
Intervention1: Hairsteticsâ?¢: The Hairsteticsâ?¢ anchoring system is comprised of a disposable cartridge pre-loaded, depending on the cartridge configuration, with 12-36 short prosthetic hair units,
Sponsors
Hairstetics Ltd
Eligibility
Inclusion criteria
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. PTT 25â?? - 35â?? f.Serum creatinine g.SGOT h.SGPT i.Alkaline phosphatase 4.A life expectancy at least of the duration of the trial. Signed informed consent and post-implantation protocol.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
Fortis Hospital
Outcome results
None listed