Phase 2 N=4 Treatment

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

Aging

Bottom Line

View on ClinicalTrials.gov: NCT00956020 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix — 0 %specimen with >25%new collagen/HPF

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Platelet rich fibrin matrix (Biological)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: The New York Eye & Ear Infirmary
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix	—	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix	—	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix	100	—
PRIMARY Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix	50	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00956020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.