NCT00956020 is a Phase 1/Phase 2 clinical trial of Platelet rich fibrin matrix in Aging, sponsored by The New York Eye & Ear Infirmary.

Who is sponsoring NCT00956020?

NCT00956020 is sponsored by The New York Eye & Ear Infirmary.

What drugs are being tested in NCT00956020?

Interventions in NCT00956020: Platelet rich fibrin matrix.

Is NCT00956020 still recruiting?

NCT00956020 is currently completed. Last updated 11 November 2015.

Are results published for NCT00956020?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-11-11 · How we verify

NCT00956020

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1/Phase 2 Results posted Last updated 11 November 2015

What this trial tests

Phase 1/Phase 2 trial testing Platelet rich fibrin matrix in Aging in 4 participants. Completed in 1 July 2011.

Timeline

1 October 2009

Primary endpoint
1 February 2011

1 July 2011

Quick facts

Lead sponsor	The New York Eye & Ear Infirmary
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	1 October 2009
Primary completion	1 February 2011
Estimated completion	1 July 2011
Sites	1 location across United States

Drugs / interventions tested

Platelet rich fibrin matrix — full drug profile →

Conditions studied

Aging — all drugs for Aging →

Sponsor

The New York Eye & Ear Infirmary — full company profile →

Who can join

Adults 25 to 75, any sex, with Aging. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix
Time frame: 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 wit
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix
Time frame: 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 pl
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix
Time frame: 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 p
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix
Time frame: 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 p
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix
Time frame: 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
Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix
Time frame: 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Aging

Currently open trials in the same condition.

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NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

Other The New York Eye & Ear Infirmary trials

Trials by the same sponsor.

NCT05324189 — Automated AI-based System for Early Diagnosis of Diabetic Retinopathy · unknown
NCT04863391 — Telemedicine in Age-Related Macular Degeneration · unknown
NCT04087356 — Age-related Macular Degeneration (AMD) and Cardiovascular Disease · unknown
NCT03918590 — Post Intravitreal Injection Topical NSAID vs. Patching · Phase 4 · unknown
NCT02984813 — Safety and Efficacy of Anti-Oxidants and Anti-inflammatory Agents in Glaucoma and Diabetic Retinopathy · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00956020 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The New York Eye & Ear Infirmary
Last refreshed: 11 November 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00956020.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing