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

NCT02316418 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-12-01

No results posted yet for this study

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

Interventions

DEVICE

Hairstetics™ anchoring system

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.

Sponsors & Collaborators

  • Hairstetics

    lead INDUSTRY

Principal Investigators

  • Igal Ruvinsky, Ph.D. · Hairstetics Ltd.

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-28
Completion
2018-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316418 on ClinicalTrials.gov