Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-30 @ 8:21 PM
Study NCT ID:
NCT04839692
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment and Augmentation of Lip Appearance in Specific Study Populations
Sponsor:
Dieter Manstein, MD
Organization:
Study Overview
Official Title:
Assessment and Augmentation of Lip Appearance in Specific Study Populations
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This study aims to learn more about the effects of aging and lip filler treatment on lips and the surrounding skin by comparing, among two different age groups of people, changes in the blood vessels and nerves, volume, color and texture change before and after lip filler treatment and pain tolerance from lip filler treatment.
Detailed Description:
This study will investigate aging of the cutaneous changes of human skin anatomy in the lips and perioral area to better understand and quantify the aging process in this, including the effect of age on lip redness. Additionally, the investigators aim to test the effects of a common lip augmentation procedure, hyaluronic-acid based fillers, on the appearance (volume, texture and color) of aging lips, in addition to the tolerability of this procedure. It is hypothesized that dermal lip fillers may decrease the redness of the lips.
Besides, the investigators want to evaluate oxytocin level changes and relate it to subjects' satisfaction after the lip filler procedure.
Besides, the investigators want to evaluate oxytocin level changes and relate it to subjects' satisfaction after the lip filler procedure.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: