Trial Outcomes & Findings for Assessment and Augmentation of Lip Appearance in Specific Study Populations (NCT NCT04839692)
NCT ID: NCT04839692
Last Updated: 2023-07-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Day 1 and Day 14
Results posted on
2023-07-28
Participant Flow
Participant milestones
| Measure |
Young Females (21-30 Years Old)
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
14
|
|
Overall Study
COMPLETED
|
22
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Young Females (21-30 Years Old)
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Assessment and Augmentation of Lip Appearance in Specific Study Populations
Baseline characteristics by cohort
| Measure |
Young Females (21-30 Years Old)
n=22 Participants
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
n=11 Participants
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
24.72 years
STANDARD_DEVIATION 2.64 • n=99 Participants
|
69.91 years
STANDARD_DEVIATION 10.97 • n=107 Participants
|
39.79 years
STANDARD_DEVIATION 22.58 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
11 participants
n=107 Participants
|
33 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Pre 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).
Outcome measures
| Measure |
Young Females (21-30 Years Old)
n=22 Participants
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
n=11 Participants
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
|---|---|---|
|
Change in Lip Vessel's Thickness
|
0.833 µm
Standard Deviation 1.334
|
0.360 µm
Standard Deviation 1.543
|
SECONDARY outcome
Timeframe: Day 1This 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.
Outcome measures
| Measure |
Young Females (21-30 Years Old)
n=22 Participants
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
n=11 Participants
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
|---|---|---|
|
Wong-Baker FACES Pain Rating Scale
|
2.9 score on a scale
Standard Deviation .5
|
3.5 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: D1 and D14The 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
Outcome measures
| Measure |
Young Females (21-30 Years Old)
n=22 Participants
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
n=11 Participants
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
|---|---|---|
|
Lip Fullness Measurement (Measures the Increase of Lip's Size After the Procedure)
|
1.14 units on a scale
Standard Deviation 0.52
|
0.78 units on a scale
Standard Deviation 0.34
|
Adverse Events
Young Females (21-30 Years Old)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Post Menopausal Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Young Females (21-30 Years Old)
n=22 participants at risk
young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
Post Menopausal Females
n=11 participants at risk
post menopausal females from all phototypes who have thin or moderately thick lips
Hyaluronic acid filler: Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Asymmetry
|
9.1%
2/22 • Number of events 2 • 21 days
Minimal-risk study with healthy participants. Two subjects from the young arm presented lip asymmetry as an adverse event.
|
0.00%
0/11 • 21 days
Minimal-risk study with healthy participants. Two subjects from the young arm presented lip asymmetry as an adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place