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NCT00874094 · ClinicalTrials.gov registry record · Phase 1

Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds

A Phase 1 study of Nasolabial Folds, sponsored by The New York Eye & Ear Infirmary.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT00874094: Completed Phase 1 study of Nasolabial Folds, sponsored by The New York Eye & Ear Infirmary.

NCT00874094 is a Phase 1 study of Nasolabial Folds that has completed, run by The New York Eye & Ear Infirmary. The registered enrollment target is 15 participants, below the 63-participant average among 4 other Nasolabial Folds trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00874094, a Phase 1 study of Nasolabial Folds, has completed, sponsored by The New York Eye & Ear Infirmary.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.

Primary Outcome

Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.

Conditions Studied

Interventions

  • BIOLOGICAL Platelet rich fibrin matrix

Study Locations (1)

New York

  • The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite - Chappaqua

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2008-04
Est. Completion 2009-07
Phase Phase 1
The New York Eye & Ear Infirmary

12 total trials

What the finished NCT00874094 record still lists

NCT00874094 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 63-participant average among 4 other Nasolabial Folds trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Nasolabial Folds appearing as the primary indexed condition, and to 1 intervention - of which Platelet rich fibrin matrix is the first listed.

NCT00874094 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00874094 about?

NCT00874094 is a clinical study titled "Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds". Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the s...

What is the current status of trial NCT00874094?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2008-04. Estimated completion is 2009-07.

What conditions does trial NCT00874094 study?

This clinical trial studies the following conditions: Nasolabial Folds.

What interventions are being tested in trial NCT00874094?

The interventions under investigation include: Platelet rich fibrin matrix (BIOLOGICAL).

Who is sponsoring clinical trial NCT00874094?

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

Where is trial NCT00874094 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00874094, the US trial registry maintained by the National Library of Medicine. NCT00874094 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.