Hairstetics™ Anchoring System in Female Pattern Hair Loss (HAS-FPHL)

NCT02316418 | Unknown

• 1 other identifier: HET-11
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to provide evidence of safety and preliminary performance of the Hairstetics™ anchoring system in female subjects affected with androgenetic alopecia (female pattern hair loss; (FPHL)). The study will also help to determine whether the Hairstetics™ 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.

Conditions

Female Pattern Baldness; Alopecia, Androgenetic

Keywords

Hairstetics™ anchoring system; hair extensions

Outcome Measures

Primary Outcomes (1)

• Percent of subjects with at least 70% of the hair extensions

  Percent of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit.

  6 months after attachment of hair extensions

Secondary Outcomes (4)

• Subject aesthetic satisfaction

  at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment

• Investigator aesthetic satisfaction

  at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment

• Proportion of hair extensions remaining at place at the different visits.

  from attachment of hair extensions through study completion, an average of 6 months

• Pain rating during procedure

  At implantation

Other Outcomes (3)

• Device ease of use

  At implantation

• Implant retrieval rate

  from implantation through study completion, an average of 7 months

• Cumulative incidence of adverse events

  through study completion, an average of 7.5 months

Study Arms (1)

Hairstetics™ anchoring system

EXPERIMENTAL

Prosthetic hair implantation using the Hairstetics™ anchoring system, followed by attachment of hair extensions.

Device: Hairstetics™ anchoring system

Interventions

Hairstetics™ anchoring system DEVICE

Overall, up to 360 prosthetic hair implants will be set in the scalp. The procedure will be performed in accordance with the instructions in the device Instructions for Use. Training and certification of operators by the Sponsor is a prerequisite for use of the study device by the former. Hair extensions will be attached to the fibers four weeks after the implantation.

Hairstetics™ anchoring system

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 yrs.
• Female patients with androgenetic alopecia (FPHL).
• Pre-treatment hematology and coagulation values within the limits:
• Hemoglobin ≥ 10 g/dl (g/100 ml)
• Platelets ≥ 150 x 10\^9/L (10\^3/mm\^3)
• WBC ≥ 3.0 x 10\^9/L (10\^3/mm\^3)
• INR 0.8 - 1.2 ---
• PTT 25" - 35"
• Serum creatinine \< 2 mg/dl
• SGOT \< 1.5 x ULN (Upper Limit of Norm)
• SGPT \< 1.5 x ULN
• Alkaline phosphatase \< 1.5 x ULN
• A life expectancy at least of the duration of the trial.
• Signed informed consent and post-implantation protocol.

You may not qualify if:

• Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study.
• 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.
• Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy.
• Patients on anticoagulant treatment.
• 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 corticosteroid treatment) or patients with an immunocompromised state for any reason.
• Bleeding disorder.
• 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.
• Use of illegal substances.
• Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative.
• Quantitative β-HCG ≥ 5 mIU/mL (IU/L) in women of childbearing potential.
• Lactating and/or breastfeeding women.
• 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.
• 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.

Sponsors & Collaborators

• Hairstetics: lead

Study Sites (1)

Fortis Hospital

New Delhi, National Capital Territory of Delhi, 110088, India

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Igal Ruvinsky, Ph.D.

  Hairstetics Ltd.

  STUDY DIRECTOR

Central Study Contacts

Igal Ruvinsky, Ph.D.

CONTACT

+972-72-2501630; igal.r@hairstetics.com

Boaz Shenhav

CONTACT

+972-72-2501630; boaz.s@hairstetics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)