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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
Sponsor:
Information provided by (Responsible Party):
Anthony P. Sclafani, The New York Eye & Ear Infirmary

Tracking Information
First Submitted Date  ICMJE April 29, 2012
First Posted Date  ICMJE May 2, 2012
Results First Submitted Date  ICMJE September 22, 2016
Results First Posted Date  ICMJE November 10, 2016
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
Hair Density Change After Three Treatments [ Time Frame: 3 months after initial visit ]
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.
Change History Complete list of historical versions of study NCT01590238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • Hair follicular density change after three treatments [ Time Frame: 3 months after initial treatment ]
    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 ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Official Title  ICMJE Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alopecia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: PRFM treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2012)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • bleeding disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590238
Other Study ID Numbers  ICMJE 2012-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony P. Sclafani, The New York Eye & Ear Infirmary
Study Sponsor  ICMJE The New York Eye & Ear Infirmary
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The New York Eye & Ear Infirmary
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP