Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755595
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2021-01-25
Brief Title:
Combination Facial Aesthetic Treatment in Millennials
Sponsor:
State University of New York - Downstate Medical Center
Organization:
State University of New York - Downstate Medical Center
Study Overview
Official Title:
Combination Facial Aesthetic Treatment in Millennials
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With 63 of consumers willing to consider investing in facial aesthetics and 73 of consumers worldwide expecting to invest in aesthetic treatments in the upcoming year it is imperative to explore patient satisfaction and psychosocial impact of a multimodal aesthetic treatment in a millennial cohort The investigators hypothesize that a combination approach to facial aesthetic treatment in a millennial cohort will result in increased patient-reported satisfaction in multiple areas including perception of aging concerns and quality of life
Detailed Description:
This is a single-center prospective rater-blinded pilot study to evaluate patient satisfaction with facial aesthetic treatment using a combination of botulinum toxin and dermal fillers The three types of injectables are Botox Cosmetic onabotulinumtoxinA Juvéderm Voluma XC hyaluronic acid gel filler and Juvéderm Volbella XC hyaluronic acid gel filler Twenty individuals who belong to the millennial generation ie born between January 1 1981 and December 31 19961 and meet eligibility criteria will be enrolled Study participants will receive all three injectables during a single procedure with an optional touch-up treatment at 2 weeks The primary endpoint is the change in satisfaction after facial aesthetic treatment using the FACE-Q Satisfaction with Facial Appearance Overall Scale Other outcome measures include various FACE-Q Aesthetic scales digital skin imaging analysis photographs and rater-blinded clinical assessment using the Global Aesthetic Improvement Scale GAIS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None