Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

December 29, 2016 updated by: Anthony P. Sclafani, The New York Eye & Ear Infirmary
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • The New York Eye & Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18- 75 years old
  • frontal and/or crown alopecia

Exclusion Criteria:

  • bleeding disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with PRFM
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.
Biological: PRFM treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair Density Change After Three Treatments
Time Frame: 6 months after initial visit
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.
6 months after initial visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The New York Eye & Ear Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 29, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-1 (SUNY Upstate IRB (Upstate Medical University))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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