NCT04839692

Assessment and Augmentation of Lip Appearance in Specific Study Populations

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Dieter Manstein, MD · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lip Aging
• Lip Augmentation
• Lip

Interventions

Type	Name	Description
DRUG	Hyaluronic acid filler	Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.

Timeline

• Start date: 2021-05-07
• Primary completion: 2022-07-01
• Completion: 2022-08-01
• First posted: 2021-04-09
• Last updated: 2023-07-28
• Results posted: 2023-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study