Trial Outcomes & Findings for An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face (NCT NCT02403986)
NCT ID: NCT02403986
Last Updated: 2022-08-26
Results Overview
Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
R. Vital Skinboosters Lidocaine (Three)
Treatment with three initial sessions
Restylane Vital Skinboosters Lidocaine
|
R. Vital Skinboosters Lidocaine (Two)
Treatment with two initial sessions
Restylane Vital Skinboosters Lidocaine
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face
Baseline characteristics by cohort
| Measure |
R. Vital Skinboosters Lidocaine (Three)
n=26 Participants
Treatment with three initial sessions
Restylane Vital Skinboosters Lidocaine
|
R. Vital Skinboosters Lidocaine (Two)
n=27 Participants
Treatment with two initial sessions
Restylane Vital Skinboosters Lidocaine
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 years
n=5 Participants
|
41.0 years
n=7 Participants
|
41.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 MonthsPopulation: At 1 Month after initial treatment, there were 24 participants in Group A and 25 participants in Group B. (26 and 27 respectively randomized, as reported in Participant Flow.)
Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Outcome measures
| Measure |
R. Vital Skinboosters Lidocaine (Three)
n=24 Participants
Treatment with three initial sessions
Restylane Vital Skinboosters Lidocaine
|
R. Vital Skinboosters Lidocaine (Two)
n=25 Participants
Treatment with two initial sessions
Restylane Vital Skinboosters Lidocaine
|
|---|---|---|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
1 month
|
91.7 % improved participants
Interval 73.0 to 99.0
|
80.0 % improved participants
Interval 59.3 to 93.2
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
3 months
|
79.2 % improved participants
Interval 57.8 to 92.9
|
72.0 % improved participants
Interval 50.6 to 87.9
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
6 months
|
78.3 % improved participants
Interval 56.3 to 92.5
|
58.3 % improved participants
Interval 36.6 to 77.9
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
9 months
|
77.3 % improved participants
Interval 54.6 to 92.2
|
50.0 % improved participants
Interval 29.1 to 70.9
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
12 months
|
81.8 % improved participants
Interval 58.1 to 94.6
|
60.9 % improved participants
Interval 38.5 to 80.3
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
15 months
|
81.0 % improved participants
Interval 58.1 to 94.6
|
68.2 % improved participants
Interval 45.1 to 86.1
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject
18 months
|
81.0 % improved participants
Interval 58.1 to 94.6
|
77.3 % improved participants
Interval 54.6 to 92.2
|
PRIMARY outcome
Timeframe: Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 MonthsPopulation: At 1 Month after initial treatment, there were 24 participants in Group A and 25 participants in Group B. (26 and 27 respectively randomized, as reported in Participant Flow.)
Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved.
Outcome measures
| Measure |
R. Vital Skinboosters Lidocaine (Three)
n=24 Participants
Treatment with three initial sessions
Restylane Vital Skinboosters Lidocaine
|
R. Vital Skinboosters Lidocaine (Two)
n=25 Participants
Treatment with two initial sessions
Restylane Vital Skinboosters Lidocaine
|
|---|---|---|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
1 month
|
100.0 % improved participants
Interval 85.8 to 100.0
|
96.0 % improved participants
Interval 79.6 to 99.9
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
3 months
|
95.8 % improved participants
Interval 78.9 to 99.9
|
92.0 % improved participants
Interval 74.0 to 99.0
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
6 months
|
82.6 % improved participants
Interval 61.2 to 95.0
|
87.5 % improved participants
Interval 67.6 to 97.3
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
9 months
|
81.8 % improved participants
Interval 59.7 to 94.8
|
70.8 % improved participants
Interval 48.9 to 87.4
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
12 months
|
86.4 % improved participants
Interval 65.1 to 97.1
|
87.0 % improved participants
Interval 66.4 to 97.2
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
15 months
|
95.2 % improved participants
Interval 76.2 to 99.9
|
95.5 % improved participants
Interval 77.2 to 99.9
|
|
Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator
18 months
|
100.0 % improved participants
Interval 83.9 to 100.0
|
90.9 % improved participants
Interval 70.8 to 98.9
|
Adverse Events
R. Vital Skinboosters Lidocaine (Three)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
R. Vital Skinboosters Lidocaine (Two)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R. Vital Skinboosters Lidocaine (Three)
n=26 participants at risk
Treatment with three initial sessions
Restylane Vital Skinboosters Lidocaine
|
R. Vital Skinboosters Lidocaine (Two)
n=27 participants at risk
Treatment with two initial sessions
Restylane Vital Skinboosters Lidocaine
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
3.8%
1/26 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
General disorders
Face oedema
|
3.8%
1/26 • Number of events 1 • 18 months
|
0.00%
0/27 • 18 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/26 • 18 months
|
3.7%
1/27 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
R. Vital Skinboosters Lidocaine (Three)
n=26 participants at risk
Treatment with three initial sessions
Restylane Vital Skinboosters Lidocaine
|
R. Vital Skinboosters Lidocaine (Two)
n=27 participants at risk
Treatment with two initial sessions
Restylane Vital Skinboosters Lidocaine
|
|---|---|---|
|
Infections and infestations
Influenza
|
15.4%
4/26 • Number of events 5 • 18 months
|
11.1%
3/27 • Number of events 3 • 18 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
30.8%
8/26 • Number of events 12 • 18 months
|
18.5%
5/27 • Number of events 7 • 18 months
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Number of events 2 • 18 months
|
0.00%
0/27 • 18 months
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
7.7%
2/26 • Number of events 2 • 18 months
|
0.00%
0/27 • 18 months
|
|
General disorders
Implant site swelling
|
7.7%
2/26 • Number of events 5 • 18 months
|
7.4%
2/27 • Number of events 6 • 18 months
|
|
General disorders
Implant site nodule
|
0.00%
0/26 • 18 months
|
7.4%
2/27 • Number of events 3 • 18 months
|
|
General disorders
Implant site pain
|
0.00%
0/26 • 18 months
|
7.4%
2/27 • Number of events 6 • 18 months
|
Additional Information
Cecilia Skoglund, Manager Study strategy and publications
Q-Med AB
Phone: 46 18 474 9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER