Trial Outcomes & Findings for Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation (NCT NCT02703948)
NCT ID: NCT02703948
Last Updated: 2022-08-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Restylane Silk With Lidocaine
Restylane Silk with Lidocaine
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
Baseline characteristics by cohort
| Measure |
Restylane Silk With Lidocaine
n=60 Participants
Restylane Silk with Lidocaine
|
|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Restylane Silk With Lidocaine
n=60 Participants
Restylane Silk with Lidocaine
|
|---|---|
|
Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine
|
11 Participants
|
Adverse Events
Restylane Silk With Lidocaine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Silk With Lidocaine
n=60 participants at risk
Restylane Silk with Lidocaine
|
|---|---|
|
General disorders
Bruising
|
6.7%
4/60 • Number of events 5 • Adverse event data was collected from screening through 12 weeks
|
|
General disorders
Pain
|
1.7%
1/60 • Number of events 2 • Adverse event data was collected from screening through 12 weeks
|
|
General disorders
Swelling
|
13.3%
8/60 • Number of events 14 • Adverse event data was collected from screening through 12 weeks
|
|
Gastrointestinal disorders
Chapped Lips
|
1.7%
1/60 • Number of events 2 • Adverse event data was collected from screening through 12 weeks
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from screening through 12 weeks
|
|
Infections and infestations
Sinusitis
|
1.7%
1/60 • Number of events 1 • Adverse event data was collected from screening through 12 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
1.7%
1/60 • Number of events 2 • Adverse event data was collected from screening through 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any and all data resulting from the Study will not be presented or published in any form or media by the PI without the prior written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER