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Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation

NCT ID: NCT00956020

Last Updated: 2015-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-07-31

Brief Summary

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Autologous platelet rich fibrin matrix will release growth factors which could increase the production of dermal proteins or affect the vascularity and status of neighboring tissues. This study is designed to evaluate the histologic and biochemical effect of injection of platelet rich fibrin matrix into the skin.

Detailed Description

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Subjects will be treated with platelet rich fibrin matrix into the skin of the inner aspect of the upper arm. Injected areas will be monitored clinically and will also undergo biopsies between 30 minutes and 12 weeks after treatment. Specimen of treated areas will undergo histologic and biochemical analysis and comparison to standard laboratory control specimen of untreated skin.

Conditions

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Aging

Keywords

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platelet rich plasma fibrin matrix dermal filler

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.

Group Type EXPERIMENTAL

Platelet rich fibrin matrix

Intervention Type BIOLOGICAL

Single treatment with platelet rich fibrin matrix

Interventions

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Platelet rich fibrin matrix

Single treatment with platelet rich fibrin matrix

Intervention Type BIOLOGICAL

Other Intervention Names

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Selphyl

Eligibility Criteria

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Inclusion Criteria

* 25 and 75 years of age

Exclusion Criteria

* collagen vascular disorders
* autoimmune diseases
* signs or history of impaired wound healing
* shall not have had any infectious or inflammatory processes at the treatment sites within the prior 6 months
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The New York Eye & Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Anthony P. Sclafani

Director of Facial Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony P Sclafani, MD

Role: PRINCIPAL_INVESTIGATOR

The NY Eye & Ear Infirmary

Locations

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The NY Eye & Ear Infirmary

New York, New York, United States

Site Status

Countries

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United States

References

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Sclafani AP, McCormick SA. Induction of dermal collagenesis, angiogenesis, and adipogenesis in human skin by injection of platelet-rich fibrin matrix. Arch Facial Plast Surg. 2012 Mar-Apr;14(2):132-6. doi: 10.1001/archfacial.2011.784. Epub 2011 Oct 17.

Reference Type RESULT
PMID: 22006233 (View on PubMed)

Other Identifiers

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09-01

Identifier Type: -

Identifier Source: org_study_id