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

The New York Eye & Ear Infirmary

Status and phase: Completed; Phase 2; Phase 1

Conditions: Aging

Treatments: Biological: Platelet rich fibrin matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT00956020

09-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Biological: Platelet rich fibrin matrix