Platelet Rich Therapy for Facial Rejuvenation

Facial Rejuvenation Clinical Trial

Official title:

Assessing Outcomes for Platelet Rich Therapy for Facial Rejuvenation Using the FACE-Q Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730650
• Other study ID #: 15-00406
• Status: Completed
• Phase: N/A
• Start date: December 31, 2016
• Est. completion date: December 28, 2017

Study information

• Verified date: April 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 28, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Rejuvenation
• Facies

Intervention

Other:
• Platelet Rich Therapy (PRT)
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction as measured by the FACE-Q scale		1 Month Post-Surgery