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

Phase 1

Completed

• Conditions: Aging
• Interventions: Biological: Platelet rich fibrin matrix

• Registration Number: NCT00956020
• Lead Sponsor: The New York Eye & Ear Infirmary

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.

Study Timeline

• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-10
• Primary Completion: 2011-02
• Study Completion: 2011-07
• Results First Submitted: 2013-05-02
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-11
• Last Update Submitted: 2015-11-11
• Results First Posted: 2015-12-16
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Platelet rich fibrin matrix	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.

Primary Outcome Measures

Name	Time	Method
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix	10 weeks after treatment	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 6 Weeks After Treatment With Platelet Rich Fibrin Matrix	6 weeks after treatment	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 12 Weeks After Treatment With Platelet Rich Fibrin Matrix	12 weeks after treatment	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 2 Weeks After Treatment With Platelet Rich Fibrin Matrix	2 weeks after treatment	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 Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix	1 week after treatment	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 Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix	6 weeks after treatment	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	10 weeks after treatment	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 Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix	30 minutes after treatment	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 2 Weeks After Treatment With Platelet Rich Fibrin Matrix	2 weeks after treatment	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 Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix	30 minutes after treatment	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	1 week after treatment	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 12 Weeks After Treatment With Platelet Rich Fibrin Matrix	12 weeks after treatment	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.

Trial Locations

Locations (1)

The NY Eye & Ear Infirmary; 🇺🇸 New York, New York, United States