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

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ClinicalTrials.gov Identifier: NCT02316418
Recruitment Status : Not yet recruiting
First Posted : December 12, 2014
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hairstetics

Brief 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.


Condition or disease Intervention/treatment Phase
Female Pattern Baldness Alopecia, Androgenetic Device: Hairstetics™ anchoring system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Safety and Efficacy Evaluation of Hairstetics™ Anchoring System for Hair Extensions in Female Pattern Hair Loss
Study Start Date : January 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hairstetics™ anchoring system
Prosthetic hair implantation using the Hairstetics™ anchoring system, followed by attachment of hair extensions.
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Subject aesthetic satisfaction [ Time Frame: at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment ]
    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).

  2. Investigator aesthetic satisfaction [ Time Frame: at the time of enrolment, after attaching hair extensions and 3 and 6 months after the study treatment ]
    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.

  3. 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 ]
  4. Pain rating during procedure [ Time Frame: At implantation ]
    Pain rating, based on a visual analogue numeric pain rating scale (on a scale of 0-10).


Other Outcome Measures:
  1. Device ease of use [ Time Frame: At implantation ]
    Ease of use of the device, based on a user questionnaire responses (on a scale of 1-10).

  2. Implant retrieval rate [ Time Frame: from implantation through study completion, an average of 7 months ]
  3. Cumulative incidence of adverse events [ Time Frame: through study completion, an average of 7.5 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 19 yrs.
  2. Female patients with androgenetic alopecia (FPHL).
  3. Pre-treatment hematology and coagulation values within the limits:

    1. Hemoglobin ≥ 10 g/dl (g/100 ml)
    2. Platelets ≥ 150 x 10^9/L (10^3/mm^3)
    3. WBC ≥ 3.0 x 10^9/L (10^3/mm^3)
    4. INR 0.8 - 1.2 ---
    5. PTT 25" - 35"
    6. Serum creatinine < 2 mg/dl
    7. SGOT < 1.5 x ULN (Upper Limit of Norm)
    8. SGPT < 1.5 x ULN
    9. Alkaline phosphatase < 1.5 x ULN
  4. A life expectancy at least of the duration of the trial.
  5. Signed informed consent and post-implantation protocol.

Exclusion Criteria:

  1. Prosthetic hair implantation or hair transplantation in the 6 months preceding enrollment to this study.
  2. 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.
  3. Patients currently receiving, or that have received within the past 3 months, radio- and/or chemotherapy.
  4. Patients on anticoagulant treatment.
  5. 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.
  6. Bleeding disorder.
  7. 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.
  8. Use of illegal substances.
  9. Participation in another interventional study, unless discussed with and approved by the Sponsor or Sponsor's authorized representative.
  10. Quantitative β-HCG ≥ 5 mIU/mL (IU/L) in women of childbearing potential.
  11. Lactating and/or breastfeeding women.
  12. 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.
  13. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316418


Contacts
Contact: Igal Ruvinsky, Ph.D. +972-72-2501630 igal.r@hairstetics.com
Contact: Boaz Shenhav +972-72-2501630 boaz.s@hairstetics.com

Locations
India
Fortis Hospital Not yet recruiting
New Delhi, Delhi, India, 110088
Contact: Manjul Agrawal, MD       drmanjulagarwal@gmail.com   
Sponsors and Collaborators
Hairstetics
Investigators
Study Director: Igal Ruvinsky, Ph.D. Hairstetics Ltd.

Responsible Party: Hairstetics
ClinicalTrials.gov Identifier: NCT02316418     History of Changes
Other Study ID Numbers: HET-11
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hairstetics:
Hairstetics™ anchoring system
hair extensions

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical