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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

August 10, 2009
April 29, 2012
October 2009
February 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00956020 on ClinicalTrials.gov Archive Site
Changes in local skin blood flow after treatment with platelet rich fibrin matrix [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation
Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation

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.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Facial Rhytids
Biological: Platelet rich fibrin matrix
Single treatment with platelet rich fibrin matrix
Other Name: Selphyl
Experimental: Treatment
Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.
Intervention: Biological: Platelet rich fibrin matrix
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
25 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956020
09-01
No
Anthony P. Sclafani, The New York Eye & Ear Infirmary
The New York Eye & Ear Infirmary
Not Provided
Principal Investigator: Anthony P Sclafani, MD The NY Eye & Ear Infirmary
The New York Eye & Ear Infirmary
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP