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Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

This study is ongoing, but not recruiting participants.
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: April 3, 2013
Last verified: April 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
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 The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • Hair Density Change after Three Treatments [ Time Frame: 3 months after initial visit ] [ Designated as safety issue: No ]
    Difference in hair density index at calibrated distance from glabella in a 2 cm x 2 cm square between initial visit and 3 month follow up visit.


Secondary Outcome Measures:
  • Hair follicular density change after three treatments [ Time Frame: 3 months after initial treatment ] [ Designated as safety issue: No ]
    Difference in follicular density at a calibrated distance from the glabella in a 2 cm x 2 cm square measured using digital photographs taken at 3 month follow up visit and compared to pre-treatment visit.

  • Hair Density Change after Treatment [ Time Frame: 1, 2 and 6 months after initial visit ] [ Designated as safety issue: No ]
    Difference in hair density index at a calibrated distance from glabella in a 2 cm x 2 cm square between initial visit and 1, 2 and 6 month follow up visit.

  • Hair follicular density change after treatment [ Time Frame: 1, 2 and 6 months after initial visit ] [ Designated as safety issue: No ]
    Differences in hair follicular density at a calibrated distance from the glabella in a 2 cm x 2 cm square measured using digital photographs taken at 1,2 and 6 month follow up visit and compared to pre- treatment photographs.


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • bleeding disorder
  Contacts and Locations
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

No publications provided

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
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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 May 23, 2013