Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730650
Other study ID # 15-00406
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03537456 - Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation N/A
Completed NCT02107157 - Clinical and Histological Evaluation of the Picosure 755nm Laser With Cap Array for Facial Rejuvenation N/A
Completed NCT03962621 - A Study of the Efficacy of Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation N/A
Completed NCT04643977 - Assessment of the Safety and Efficacy of the Dermal Filler "mARG-01-17" in Facial Rejuvenation Therapy N/A