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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony P. Sclafani, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00956020
First received: August 10, 2009
Last updated: April 29, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Facial Rhytids
Biological: Platelet rich fibrin matrix
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation

Further study details as provided by The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • Changes in dermal and subdermal protein content after treatment with platelet rich fibrin matrix compared to control specimen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in local skin blood flow after treatment with platelet rich fibrin matrix [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Biological: Platelet rich fibrin matrix
Single treatment with platelet rich fibrin matrix
Other Name: Selphyl

Detailed Description:

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 over a 12 week period. Specimen of treated and control areas will undergo histologic and biochemical analysis and comparison.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956020

Locations
United States, New York
The NY Eye & Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Investigators
Principal Investigator: Anthony P Sclafani, MD The NY Eye & Ear Infirmary
  More Information

Publications:
Responsible Party: Anthony P. Sclafani, Director of Facial Plastic Surgery, The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00956020     History of Changes
Other Study ID Numbers: 09-01
Study First Received: August 10, 2009
Last Updated: April 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Eye & Ear Infirmary:
platelet rich plasma
fibrin matrix
dermal filler

ClinicalTrials.gov processed this record on November 25, 2014