- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730650
Platelet Rich Therapy for Facial Rejuvenation
Assessing Outcomes for Platelet Rich Therapy for Facial Rejuvenation Using the FACE-Q Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To assess patient-reported satisfaction of using platelet rich therapy for facial rejuvenation using a validated questionnaire (the FACE-Q scale). This is a prospective study of patients who will undergo platelet-rich therapy for facial rejuvenation at NYU Langone Medical Center. Platelet rich therapy (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. However, while platelet rich therapy for facial enrichment continues to gain popularity; little evidence exists to support its use in the current literature. Therefore, this study sets out to determine patient satisfaction as well as quality of life following PRT for facial rejuvenation. PRT has been previously used successfully in facial plastic surgery and is being offered as an option as part of standard of care for facial rejuvenation (Sclafani).
Subjects will be identified by the principal investigator as they present to the office for facial rejuvenation and are interested in an alternative to soft tissue fillers. All such patients will be given PRT as an alternative option for facial rejuvenation and any patient who agrees to this therapy will be enrolled in the study. Subject enrollment will continue until a total of 30 subjects are recruited.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females
- Ages 21 - 80
- Patients of all racial and ethnic origins
- Patients of Dr. Hazen undergoing facial rejuvenation
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Platelet Rich Therapy
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Satisfaction as measured by the FACE-Q scale
Time Frame: 1 Month Post-Surgery
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1 Month Post-Surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexes Hazen, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-00406
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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