MGH Clinical Unit for Research Trials & Outcomes Research
Boston, Massachusetts, 02114, United States
NCT Number: NCT04839692
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.
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Notify Me21 year and older
Female
Interventional
Phase 4
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
Time frame: Day 1 and Day 14
Pre and post-treatment lip vessel thickness was measured in µm using Optical Coherence Tomography-Angiography imaging. For each age group, pre and post-treatment means were calculated.
The difference between the post and the pre-treatment means is shown below (post-treatment mean - pre-treatment mean).
Time frame: Day 1
This scale will be used to record the subject's overall pain from the procedure. There are 6 faces ranging from 0=no pain to 10=the worst pain.
Time frame: D1 and D14
The Lip Fullness Grading Scale was used to measure the size of the lips before and after the procedure in both groups. The result presented below is the difference between the means after and before the procedures for each group.
min value: 0 - very thin lips - worse outcome Max value: 4 - full lips- a better outcome
Dieter Manstein, MD
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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