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Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony P. Sclafani, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01590238
First received: April 29, 2012
Last updated: December 29, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Alopecia Biological: PRFM treatment Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Further study details as provided by Anthony P. Sclafani, The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • bleeding disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590238

Locations
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
Study First Received: April 29, 2012
Results First Received: September 22, 2016
Last Updated: December 29, 2016

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

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

ClinicalTrials.gov processed this record on June 26, 2017