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
|Condition or disease||Intervention/treatment||Phase|
|Alopecia||Biological: PRFM treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||November 2013|
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.
- 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.
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|