Hairstetics™ Anchoring System in Female Pattern Hair Loss (HAS-FPHL) (HAS-FPHL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02316418|
Recruitment Status : Not yet recruiting
First Posted : December 12, 2014
Last Update Posted : December 1, 2016
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|
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.
- 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.
- 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).
- 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.
- 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 ]Pain rating, based on a visual analogue numeric pain rating scale (on a scale of 0-10).
- 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).
- Implant retrieval rate [ Time Frame: from implantation through study completion, an average of 7 months ]
- Cumulative incidence of adverse events [ Time Frame: through study completion, an average of 7.5 months ]
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
|Contact: Igal Ruvinsky, Ph.D.||+firstname.lastname@example.org|
|Contact: Boaz Shenhavemail@example.com|
|Fortis Hospital||Not yet recruiting|
|New Delhi, Delhi, India, 110088|
|Contact: Manjul Agrawal, MD firstname.lastname@example.org|
|Study Director:||Igal Ruvinsky, Ph.D.||Hairstetics Ltd.|