NCT02730650

Brief Summary

This study will be a prospective study of patients who undergo platelet-rich therapy (PRT) for facial rejuvenation at NYU Langone Medical Center. PRT has been increasingly used for wound healing, fat grafting, hemostasis as well as facial enhancement. PRT involves injection of patient's own platelets and fibrin, and has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques. Through the use of pre and post treatment photos, in addition to the FACE-Q Questionnaire and a clinician assessment, it is our hope that we will confirm the rejuvenating capabilities of PRT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 31, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2017

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

April 1, 2016

Last Update Submit

April 24, 2019

Conditions

Keywords

FACE-QPlatelet Rich TherapyPRT

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction as measured by the FACE-Q scale

    1 Month Post-Surgery

Study Arms (1)

Platelet Rich Therapy

EXPERIMENTAL

Each subject will receive six injections of Platelet Rich Plasma (PRP) at designated points on each side of their face (twelve total). Injection points are spaced evenly across the inferior border of the cheek and mid-cheek, and are consistent on each patient. Patients will receive a post-injection phone call within 48 hours of the procedure. Photographs will be taken at two time points as part of the research to serve as a point of comparison before and after platelet rich plasma. Patients will receive the Global Aesthetic Improvement Scale amd tje Face-Q Questionnaire 1 month post-op

Other: Platelet Rich Therapy (PRT)

Interventions

Platelet Rich Therapy (PRT) involves injection of patient's own platelets and fibrin.Topical anesthetic will be applied to the face for a period of fifteen minutes prior to the injection. For PRP preparation, 8 cc of blood will be collected from each patient just before each procedure. Approximately 0.3-0.4 cc of PRP will be injected into each standardized injection point in a superficial manner. The injections points are 6 points on each side of the face along the inferior border of cheek and mid-cheek (12 total). The PRP injection will be followed by 10-15 minutes of icing.

Platelet Rich Therapy

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females
  • Ages 21 - 80
  • Patients of all racial and ethnic origins
  • Patients of Dr. Hazen undergoing facial rejuvenation

You may not qualify if:

  • Patients undergoing facial rejuvenation using other methods including botox injections, chemical peels, face lifts and others.
  • Patients using blood thinners that cannot be stopped
  • Patients who have used aspirin within a week of the procedure date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Alexes Hazen, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 6, 2016

Study Start

December 31, 2016

Primary Completion

December 1, 2017

Study Completion

December 28, 2017

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations