Hairstetics Hair Implant Device Safety and Efficacy

August 8, 2017 updated by: Hairstetics

Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study

This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study.

The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Cabinet du Dr G. Beilin
        • Contact:
          • Ghislaine Beilin, MD
      • Paris, France
        • Recruiting
        • Cabinet médical du Dr Jack Smadja
        • Contact:
          • Jack Smadja, MD
      • Paris, France
        • Recruiting
        • Georges Mandel Office Surgery Clinic
        • Contact:
          • Marc Divaris, MD
  • India
      • Gurgaon, India, 122002
        • Recruiting
        • Paras Hospital
        • Contact:
          • Anil Ganjoo, MD
      • New Delhi, India, 110088
        • Recruiting
        • Fortis Hospital
        • Contact:
          • Manjul Agrawal, MD
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Egoclinic
        • Contact:
          • Irinel Nedelcu, MD
      • Bucharest, Romania
        • Recruiting
        • Metropolitan Hospital
        • Contact:
          • Radu Jecan, MD
  • United Kingdom
      • London, United Kingdom, W1G7JA
        • Recruiting
        • Revere clinic
        • Contact:
          • Sach Mohan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is ≥ 19 years old.
  2. Subject has hair loss and has chosen to undergo synthetic hair implantation.
  3. Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
  4. Subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is NOT suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
  5. Subject has Good general health.
  6. Woman of child bearing potential must have a negative pregnancy test.
  7. Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.

Exclusion Criteria:

  1. Previous synthetic hair implantation or hair transplantation in the past 6 months.
  2. Currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator.
  3. Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
  4. Currently using steroid product with Immunosuppressive treatment.
  5. Impaired coagulation.
  6. Serious illness that may affect subject compliance to protocol.
  7. Subject is using illegal drugs.
  8. Participating in other clinical study.
  9. Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
  10. For woman: Pregnancy or breast feeding.
  11. Known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hairstetics hair implant device
Subjects will undergo the Hairstetics prosthetic hair implantation starting with a test of up to 100 fibers and up to 2 additional implantation sessions with up to 1500 fibers overall per subject. The implantation will be carried out according to the device IFU.
Device: Hairstetics hair implant device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acceptable number, duration and severity of expected adverse device/procedure effects
Time Frame: 3 months following implantation
3 months following implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hairstetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HET-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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