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Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

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ClinicalTrials.gov Identifier: NCT01590238
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : November 10, 2016
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Alopecia Biological: PRFM treatment Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Study Start Date : May 2012
Primary Completion Date : September 2013
Study Completion Date : November 2013
Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • bleeding disorder
Contacts and Locations

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): NCT01590238

United States, New York
The New York Eye & Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
The New York Eye & Ear Infirmary
More Information

Responsible Party: Anthony P. Sclafani, Director of Facial Plastic Surgery, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT01590238     History of Changes
Other Study ID Numbers: 2012-1
First Posted: May 2, 2012    Key Record Dates
Results First Posted: November 10, 2016
Last Update Posted: February 15, 2017
Last Verified: December 2016

Keywords provided by Anthony P. Sclafani, The New York Eye & Ear Infirmary:

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