Facial RejuvenationNCT02730650
Platelet Rich Therapy for Facial Rejuvenation
A study testing Platelet Rich Therapy (PRT) in people with Facial Rejuvenation, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Rejuvenation
- What is being tested?
- Platelet Rich Therapy (PRT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2016to 28 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- Ages 21 - 80
- Patients of all racial and ethnic origins
- Patients of Dr. Hazen undergoing facial rejuvenation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Assessing Outcomes for Platelet Rich Therapy for Facial Rejuvenation Using the FACE-Q Questionnaire
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.
Read the 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.
- Conditions
- Facial Rejuvenation
- Being tested
- Platelet Rich Therapy (PRT)
- Keywords
- FACE-Q, Platelet Rich Therapy, PRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Therapy (PRT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Platelet Rich Therapy (PRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction as measured by the FACE-Q scale
Measured: 1 Month Post-Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start31 Dec 2016
- Primary completion1 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial RejuvenationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexes Hazen, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730650
- Sponsor's protocol ID
- 15-00406
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2016
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Outcomes for Platelet Rich Therapy for Facial Rejuvenation Using the FACE-Q Questionnaire
- ClinicalTrials.gov ID
- NCT02730650
- Acronym / sponsor ID
- 15-00406
- Conditions
- Facial Rejuvenation
- Keywords
- FACE-Q, Platelet Rich Therapy, PRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 31 Dec 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Therapy | Experimental | Other: Platelet Rich Therapy (PRT)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 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- Ages 21 - 80
- Patients of all racial and ethnic origins
- Patients of Dr. Hazen undergoing facial rejuvenation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Platelet Rich Therapy |
Primary outcome
Patient Satisfaction as measured by the FACE-Q scale
Time frame: 1 Month Post-Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexes Hazen, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Therapy (PRT) in people with Facial Rejuvenation, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction as measured by the FACE-Q scale (time frame: 1 Month Post-Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.