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NCT01590238 · ClinicalTrials.gov registry record · Phase 3

Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

A Phase 3 study, sponsored by The New York Eye & Ear Infirmary.

Completed
Registry status
Phase 3
Development phase
15
Enrollment target

NCT01590238: Completed Phase 3 study, sponsored by The New York Eye & Ear Infirmary.

NCT01590238 is a Phase 3 study that has completed, run by The New York Eye & Ear Infirmary. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01590238, a Phase 3 study, has completed, sponsored by The New York Eye & Ear Infirmary.

COMPLETED
Registry status
Phase 3
Development phase
15 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BIOLOGICAL PRFM treatment

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2012-05
Est. Completion 2013-11
Phase Phase 3
The New York Eye & Ear Infirmary

12 total trials

What the finished NCT01590238 record still lists

NCT01590238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which PRFM treatment is the first listed.

NCT01590238 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01590238 about?

NCT01590238 is a clinical study titled "Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)". 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 t...

What is the current status of trial NCT01590238?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2012-05. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01590238?

The interventions under investigation include: PRFM treatment (BIOLOGICAL).

Who is sponsoring clinical trial NCT01590238?

This trial is sponsored by The New York Eye & Ear Infirmary, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01590238's enrollment target sits among peer trials

15 1977th of 2000 higher than 18 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01590238, the US trial registry maintained by the National Library of Medicine. NCT01590238 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.