Hairstetics Hair Implant Device Safety and Efficacy

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02856308
• Other study ID #: HET-03
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2016
• Last updated: August 8, 2017
• Start date: March 2014
• Est. completion date: September 2018

Study information

• Verified date: August 2017
• Source: Hairstetics
• Contact: Igal Ruvinsky, PhD
• Phone: +972-72-2501630
• Email: igal.r[@]hairstetics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia

Intervention

Device:
• Hairstetics hair implant device

Locations

Country	Name	City	State
France	Cabinet du Dr G. Beilin	Paris
France	Cabinet médical du Dr Jack Smadja	Paris
France	Georges Mandel Office Surgery Clinic	Paris
India	Paras hospital	Gurgaon
India	Fortis Hospital	New Delhi
Romania	Egoclinic	Bucharest
Romania	Metropolitan hospital	Bucharest
United Kingdom	Revere clinic	London

Sponsors (1)

Lead Sponsor	Collaborator
Hairstetics

Countries where clinical trial is conducted

France,  India,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptable number, duration and severity of expected adverse device/procedure effects		3 months following implantation