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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alopecia
Intervention Biological: PRFM treatment
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment With PRFM
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 15
Completed 13
Not Completed 2
Arm/Group Title Treatment With PRFM
Hide Arm/Group Description

Subjects with androgenetic alopecia clinically diagnosed were 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.

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.

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
43.2  (18.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
Hair density index measured prior to intervention   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of pre treatment value
Number Analyzed 15 participants
100  (0)
[1]
Measure Description: Hair density as measured with proprietary hair densitometer in a 2cm x 2cm square in the midline at a predetermined distance from the nasal root (individual measurement but held constant for multiple measurements in the same subject over time).
1.Primary Outcome
Title Hair Density Change After Three Treatments
Hide Description 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.
Time Frame 6 months after initial visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment With PRFM
Hide Arm/Group Description:
Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: percentage of pre-treatment hair density
175.1  (46.8)
Time Frame First six months after initial treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment With PRFM
Hide Arm/Group Description

Subjects with androgenetic alopecia clinically diagnosed were 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.

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.

All-Cause Mortality
Treatment With PRFM
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With PRFM
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment With PRFM
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anthony P Sclafani, MD
Organization: New York Eye & Ear Infirmary
Phone: 212-979-4200
EMail: asclafani@nyee.edu
Layout table for additonal information
Responsible Party: Anthony P. Sclafani, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT01590238     History of Changes
Other Study ID Numbers: 2012-1
First Submitted: April 29, 2012
First Posted: May 2, 2012
Results First Submitted: September 22, 2016
Results First Posted: November 10, 2016
Last Update Posted: February 15, 2017