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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: November 11, 2015
Last verified: November 2015
Results First Received: May 2, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aging
Intervention: Biological: Platelet rich fibrin matrix

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment

Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.

Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix


Participant Flow:   Overall Study
    Treatment  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment

Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.

Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix


Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  44  (8)  
Gender  
[units: participants]
 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Primary:   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 ]

6.  Primary:   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 ]

7.  Primary:   Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix   [ Time Frame: 30 minutes after treatment ]

8.  Primary:   Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix   [ Time Frame: 1 week after treatment ]

9.  Primary:   Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix   [ Time Frame: 2 weeks after treatment ]

10.  Primary:   Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix   [ Time Frame: 6 weeks after treatment ]

11.  Primary:   Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix   [ Time Frame: 10 weeks after treatment ]

12.  Primary:   Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix   [ Time Frame: 12 weeks after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anthony Sclafani, MD
Organization: NYEEI Department of Otolaryngology
phone: 212-979-4200
e-mail: asclafani@nyee.edu


Publications of Results:

Responsible Party: Anthony P. Sclafani, 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