CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
PRFM treatmentbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01590238
NCT01590238Phase 3Completed
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Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

The New York Eye & Ear Infirmary·interventional·Posted May 2, 2012·Updated Feb 15, 2017

In Brief

A Phase 3 clinical trial evaluating PRFM treatment for Alopecia. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlopecia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.2 years ago

Interventions

PRFM treatmentbiological

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.