Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Primary Purpose
Alopecia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PRFM treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia focused on measuring alopecia
Eligibility Criteria
Inclusion Criteria:
- age 18- 75 years old
- frontal and/or crown alopecia
Exclusion Criteria:
- bleeding disorder
Sites / Locations
- The New York Eye & Ear Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with PRFM
Arm Description
Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.
Outcomes
Primary Outcome Measures
Hair Density Change After Three Treatments
Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.
Secondary Outcome Measures
Full Information
NCT ID
NCT01590238
First Posted
April 29, 2012
Last Updated
December 29, 2016
Sponsor
The New York Eye & Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT01590238
Brief Title
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Official Title
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The New York Eye & Ear Infirmary
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal findings of improvement of hair appearance after PRFM injection in the scalp suggest that PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density will be assessed by comparing pre- and post-treatment photographs and non-invasive measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with PRFM
Arm Type
Experimental
Arm Description
Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.
Intervention Type
Biological
Intervention Name(s)
PRFM treatment
Intervention Description
Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment.
Primary Outcome Measure Information:
Title
Hair Density Change After Three Treatments
Description
Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.
Time Frame
6 months after initial visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18- 75 years old
frontal and/or crown alopecia
Exclusion Criteria:
bleeding disorder
Facility Information:
Facility Name
The New York Eye & Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
We'll reach out to this number within 24 hrs