Clinical trial NCT00956020: Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation
Official title: Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aging
Keywords: platelet rich plasma
fibrin matrix
dermal filler
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 4
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 30 minutes after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 1 week after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 2 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 6 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 10 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 12 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 30 minutes after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 1 week after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 2 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 6 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 10 weeks after treatment
measure: Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The NY Eye & Ear Infirmary
state: New York
Study officials:
affiliation: The NY Eye & Ear Infirmary
name: Anthony P Sclafani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.