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: November 11, 2015
Last verified: November 2015
  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
Aging
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:
  • Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 30 minutes after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 1 week after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 10 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 30 minutes after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 1 week after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 10 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.

  • Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]
    Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.


Enrollment: 4
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 period from 30 minutes to 12 weeks after treatment.
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 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.
  Eligibility

Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
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
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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
Results First Received: May 2, 2013
Last Updated: November 11, 2015
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 August 29, 2016