Female Pattern BaldnessHAS-FPHLNCT02316418
Hairstetics™ Anchoring System in Female Pattern Hair Loss (HAS-FPHL)
A study testing Hairstetics™ anchoring system in people with Female Pattern Baldness and Alopecia, Androgenetic, run by Hairstetics at 1 site in India.
Trial 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)). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Female Pattern Baldness, Alopecia, Androgenetic
- What is being tested?
- Hairstetics™ anchoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2017to Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis Hospital
New Delhi, National Capital Territory of Delhi, 110088
Manjul Agrawal, MD, drmanjulagarwal@gmail.com
About this study
Official title: Prospective Safety and Efficacy Evaluation of Hairstetics™ Anchoring System for Hair Extensions in Female Pattern Hair Loss
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.
Read the detailed description
- Type of trial: Open label
- Study population: Female patients with androgenetic alopecia (FPHL)
- Phase: II
- Number of study arms: Single-arm
- Number of centers: Single center
- Name of study agent: Hairstetics™ hair anchoring system
- Changes in scheduling: maximal number of implants may not be modified throughout the trial.
ENDPOINTS
Primary Endpoint:
Percent of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit.
Secondary Endpoints:
- Proportion of hair extensions remaining at place at the different visits.
- Subject aesthetic satisfaction based on a satisfaction questionnaire (on a scale of 1-10).
- Investigator aesthetic satisfaction based on a satisfaction questionnaire on a scale of 1-10).
- Pain rating during procedure, based on a visual analogue numeric pain rating scale (on a scale of 0-10).
Exploratory Endpoints:
- Ease of use, based on a user questionnaire responses (on a scale of 1-10).
- Implant retrieval rate.
Safety Endpoints:
Adverse events both expected and unexpected, related or unrelated to study device or procedure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
STUDY PROCEDURE - After signing informed consent, patients will be screened for study eligibility by assessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data, medical history, physical examination, vital signs, and laboratory evaluations.
Unless the patient's participation in the trial is terminated, subjects will then be implanted with Hairstetics™ anchoring system cartridges holding up to a total of 360 of the Hairstetics™ prosthetic hair units. Complete blood count (CBC), biochemistry and coagulation panel and a quantitative β-HCG, as specified in the eligibility criteria, will be required before treatment and the test requirements specified in the inclusion criteria must be met.
Patients will be followed a week after the study implantation procedure, to ensure proper monitoring of safety events.
Hair extensions will be attached four weeks after the implantation. Patients will be followed at 3 and 6 months after the attachment of hair extensions.
This protocol will allow excision of implants.
This protocol does not provide arrangements for long-term follow-up of study participants beyond primary endpoint.
SUBJECT POPULATION - Female patients with androgenetic alopecia (female pattern hair loss; (FPHL))
STUDY DURATION - 13 months.
STATISTICAL ANALYSIS - General -
No separate Statistical Analysis Plan (SAP) document is planned. Nevertheless, if during the study, modifications to the statistical considerations will be deemed necessary, a SAP may be issued.
The study is planned as a prospective, single-arm study to assess safety and preliminary efficacy data on the treatment of female subjects affected with androgenetic alopecia (FPHL) with the Hairstetics™ anchoring system. The analysis of the endpoints is descriptive in nature; no formal statistical hypotheses will be tested.
Primary Endpoint:
The number and proportion of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit, will be presented.
Secondary Endpoints:
The proportion of hair extensions remaining in place at the different visit will be presented in a tabular form.
The aesthetic satisfaction as assessed by the subjects and the investigators will be presented in a tabular form by visit, once as continuous variables, and once as categorical variables.
The pain during the procedure will be presented in a tabular form, once as continuous variable, and once as categorical variable.
Exploratory analyses:
The ease of use will be presented in the same manner as the pain. The number and proportion of subjects for whom the implants are removed will be presented in a tabular form.
Safety endpoint:
The cumulative incidence (and 95% CI) of adverse events observed during procedure and throughout the follow-up period, will be presented in tabular format. A detailed list of all adverse events will be presented. The adverse event rate will be compiled with respect to seriousness, severity, and relationship to procedure and device. In addition, listings of all safety measures will be produced.
Baseline descriptive statistics:
Demographic, medical and clinical history variables will be tabulated. Continuous variables will be summarized by a mean, standard deviation, minimum, median and maximum, and categorical variables by a count and percentage.
Interim analysis:
No interim analysis is planned for efficacy and/or safety review.
Sample size:
No formal sample size calculations were performed. A sample size of ten subjects will provide safety and performance preliminary assessment.
- Conditions
- Female Pattern Baldness, Alopecia, Androgenetic
- Being tested
- Hairstetics™ anchoring system
- Keywords
- Hairstetics™ anchoring system, hair extensions
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hairstetics™ anchoring systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hairstetics™ anchoring system | Experimental | Prosthetic hair implantation using the Hairstetics™ anchoring system, followed by attachment of hair extensions. Receives: Device: Hairstetics™ anchoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after attachment of hair extensions
Secondary outcomes (4)
Subject aesthetic satisfaction
Satisfaction of study participants with the aesthetic appearance of their scalp will be assessed through a questionnaire. Participants will provide a numerical evaluation, on a standard scale of 1-10, of their satisfaction (with 10 being the highest grade of satisfaction).
Measured: at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment
Investigator aesthetic satisfaction
Satisfaction of Investigators with the aesthetic appearance of the scalp of study subjects will be assessed. Investigators will provide a numerical evaluation, on a standard scale of 1-10, of their satisfaction (with 10 being the highest grade of satisfaction). Digital photography and, optionally, video will be used throughout the study, starting with the screening and during every visit thereafter, to capture the general appearance of the scalp and that of the implantation area and its vicinity. Digital images may support Investigators in providing their evaluation of the procedural outcome.
Measured: 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.
Measured: from attachment of hair extensions through study completion, an average of 6 months
Pain rating during procedure
Pain rating, based on a visual analogue numeric pain rating scale (on a scale of 0-10).
Measured: At implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJan 2017
- Primary completionFeb 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern BaldnessStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hairstetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igal Ruvinsky, Ph.D., Study director, Hairstetics Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316418
- Sponsor's protocol ID
- HET-11
- Acronym
- HAS-FPHL
- Status last verified
- Nov 2016
- First submitted
- 10 Dec 2014
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Safety and Efficacy Evaluation of Hairstetics™ Anchoring System for Hair Extensions in Female Pattern Hair Loss
- ClinicalTrials.gov ID
- NCT02316418
- Acronym / sponsor ID
- HAS-FPHL / HET-11
- Conditions
- Female Pattern Baldness, Alopecia, Androgenetic
- Keywords
- Hairstetics™ anchoring system, hair extensions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HairsteticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 12 Dec 2014 (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.
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.
Detailed description
- Type of trial: Open label
- Study population: Female patients with androgenetic alopecia (FPHL)
- Phase: II
- Number of study arms: Single-arm
- Number of centers: Single center
- Name of study agent: Hairstetics™ hair anchoring system
- Changes in scheduling: maximal number of implants may not be modified throughout the trial.
ENDPOINTS
Primary Endpoint:
Percent of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit.
Secondary Endpoints:
- Proportion of hair extensions remaining at place at the different visits.
- Subject aesthetic satisfaction based on a satisfaction questionnaire (on a scale of 1-10).
- Investigator aesthetic satisfaction based on a satisfaction questionnaire on a scale of 1-10).
- Pain rating during procedure, based on a visual analogue numeric pain rating scale (on a scale of 0-10).
Exploratory Endpoints:
- Ease of use, based on a user questionnaire responses (on a scale of 1-10).
- Implant retrieval rate.
Safety Endpoints:
Adverse events both expected and unexpected, related or unrelated to study device or procedure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03.
STUDY PROCEDURE - After signing informed consent, patients will be screened for study eligibility by assessment of inclusion and exclusion criteria. Screening procedures will include collection of demographic data, medical history, physical examination, vital signs, and laboratory evaluations.
Unless the patient's participation in the trial is terminated, subjects will then be implanted with Hairstetics™ anchoring system cartridges holding up to a total of 360 of the Hairstetics™ prosthetic hair units. Complete blood count (CBC), biochemistry and coagulation panel and a quantitative β-HCG, as specified in the eligibility criteria, will be required before treatment and the test requirements specified in the inclusion criteria must be met.
Patients will be followed a week after the study implantation procedure, to ensure proper monitoring of safety events.
Hair extensions will be attached four weeks after the implantation. Patients will be followed at 3 and 6 months after the attachment of hair extensions.
This protocol will allow excision of implants.
This protocol does not provide arrangements for long-term follow-up of study participants beyond primary endpoint.
SUBJECT POPULATION - Female patients with androgenetic alopecia (female pattern hair loss; (FPHL))
STUDY DURATION - 13 months.
STATISTICAL ANALYSIS - General -
No separate Statistical Analysis Plan (SAP) document is planned. Nevertheless, if during the study, modifications to the statistical considerations will be deemed necessary, a SAP may be issued.
The study is planned as a prospective, single-arm study to assess safety and preliminary efficacy data on the treatment of female subjects affected with androgenetic alopecia (FPHL) with the Hairstetics™ anchoring system. The analysis of the endpoints is descriptive in nature; no formal statistical hypotheses will be tested.
Primary Endpoint:
The number and proportion of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit, will be presented.
Secondary Endpoints:
The proportion of hair extensions remaining in place at the different visit will be presented in a tabular form.
The aesthetic satisfaction as assessed by the subjects and the investigators will be presented in a tabular form by visit, once as continuous variables, and once as categorical variables.
The pain during the procedure will be presented in a tabular form, once as continuous variable, and once as categorical variable.
Exploratory analyses:
The ease of use will be presented in the same manner as the pain. The number and proportion of subjects for whom the implants are removed will be presented in a tabular form.
Safety endpoint:
The cumulative incidence (and 95% CI) of adverse events observed during procedure and throughout the follow-up period, will be presented in tabular format. A detailed list of all adverse events will be presented. The adverse event rate will be compiled with respect to seriousness, severity, and relationship to procedure and device. In addition, listings of all safety measures will be produced.
Baseline descriptive statistics:
Demographic, medical and clinical history variables will be tabulated. Continuous variables will be summarized by a mean, standard deviation, minimum, median and maximum, and categorical variables by a count and percentage.
Interim analysis:
No interim analysis is planned for efficacy and/or safety review.
Sample size:
No formal sample size calculations were performed. A sample size of ten subjects will provide safety and performance preliminary assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hairstetics™ anchoring system | Experimental | Device: Hairstetics™ anchoring systemProsthetic hair implantation using the Hairstetics™ anchoring system, followed by attachment of hair extensions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 19 yrs.
- Female patients with androgenetic alopecia (FPHL).
- Pre-treatment hematology and coagulation values within the limits:
- A life expectancy at least of the duration of the trial.
- Signed informed consent and post-implantation protocol.
Key exclusion criteria (13 listed)
- 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.
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™ anchoring systemOverall, 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. | Device | Hairstetics™ anchoring system |
Primary outcome
Percent of subjects with at least 70% of the hair extensions
Time frame: 6 months after attachment of hair extensions
Percent of subjects with at least 70% of the hair extensions remaining in place at the 6-month follow-up visit.
4 secondary outcomes
Subject aesthetic satisfaction
Time frame: at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment
Investigator aesthetic satisfaction
Time frame: 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.
Time frame: from attachment of hair extensions through study completion, an average of 6 months
Pain rating during procedure
Time frame: At implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Igal Ruvinsky, Ph.D. study director
Hairstetics Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hairstetics™ anchoring system in people with Female Pattern Baldness and Alopecia, Androgenetic, run by Hairstetics at 1 site in India.
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 14 inclusion and 13 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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, Ph.D. (+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?
Percent of subjects with at least 70% of the hair extensions (time frame: 6 months after attachment of hair extensions). 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 1 Dec 2016.