AlopeciaNCT02856308
Hairstetics Hair Implant Device Safety and Efficacy
A study testing Hairstetics hair implant device in people with Alopecia, run by Hairstetics at 8 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Hairstetics hair implant device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Mar 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 19 years old.
- Subject has hair loss and has chosen to undergo synthetic hair implantation.
- Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
- 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.
- Subject has Good general health.
- Woman of child bearing potential must have a negative pregnancy test.
- Subject willing to sign a written informed consent form (ICF) and the post implantation maintenance protocol.
Who cannot join
- Previous synthetic hair implantation or hair transplantation in the past 6 months.
- 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.
- Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
- Currently using steroid product with Immunosuppressive treatment.
- Impaired coagulation.
- Serious illness that may affect subject compliance to protocol.
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- Subject is using illegal drugs.
- Participating in other clinical study.
- Known allergy or hypersensitivity to Nitinol or Nickel or Titanium
- For woman: Pregnancy or breast feeding.
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
France3 sites, 3 recruiting
- Recruiting
Cabinet du Dr G. Beilin
Paris
Ghislaine Beilin, MD
- Recruiting
Cabinet médical du Dr Jack Smadja
Paris
Jack Smadja, MD
- Recruiting
Georges Mandel Office Surgery Clinic
Paris
Marc Divaris, MD
India2 sites, 2 recruiting
- Recruiting
Paras hospital
Gūrgaon, 122002
Anil Ganjoo, MD
- Recruiting
Fortis Hospital
New Delhi, 110088
Manjul Agrawal, MD
Romania2 sites, 2 recruiting
- Recruiting
Egoclinic
Bucharest
Irinel Nedelcu, MD
- Recruiting
Metropolitan hospital
Bucharest
Radu Jecan, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Revere clinic
London, W1G7JA
Sach Mohan, MD
About this study
Official title: 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.
- Conditions
- Alopecia
- Being tested
- Hairstetics hair implant device
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hairstetics hair implant deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Hairstetics hair implant device | Experimental | 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. Receives: Device: Hairstetics hair implant device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable number, duration and severity of expected adverse device/procedure effects
Measured: 3 months following implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hairstetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856308
- Sponsor's protocol ID
- HET-03
- Status last verified
- Aug 2017
- First submitted
- 7 Jul 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study
- ClinicalTrials.gov ID
- NCT02856308
- Acronym / sponsor ID
- HET-03
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HairsteticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hairstetics hair implant device | Experimental | Device: Hairstetics hair implant deviceSubjects 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is ≥ 19 years old.
- Subject has hair loss and has chosen to undergo synthetic hair implantation.
- Subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.).
- 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.
- Subject has Good general health.
Key exclusion criteria (11 listed)
- Previous synthetic hair implantation or hair transplantation in the past 6 months.
- 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.
- Currently receiving or have within the past 3 months received radiation- and/or chemotherapy.
- Currently using steroid product with Immunosuppressive treatment.
- Impaired coagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hairstetics hair implant device | Device | Hairstetics hair implant device |
Primary outcome
Acceptable number, duration and severity of expected adverse device/procedure effects
Time frame: 3 months following implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hairstetics hair implant device in people with Alopecia, run by Hairstetics at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, India, Romania, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igal Ruvinsky, PhD (+972-72-2501630, igal.r@hairstetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptable number, duration and severity of expected adverse device/procedure effects (time frame: 3 months following implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.