Trial Outcomes & Findings for Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars (NCT NCT03127384)
NCT ID: NCT03127384
Last Updated: 2022-08-26
Results Overview
Overall scar severity assessed by blinded evaluator.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
49 participants
Primary outcome timeframe
Month 3
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Split-face: Treatment/No-treatment Control
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
Completed 3 Month Visit
|
47
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Split-face: Treatment/No-treatment Control
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Subject request
|
2
|
Baseline Characteristics
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
Baseline characteristics by cohort
| Measure |
Split-face: Treatment/No-treatment Control
n=49 Participants
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
49 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Month 3Overall scar severity assessed by blinded evaluator.
Outcome measures
| Measure |
Split-face: Treatment/No-treatment Control
n=47 Participants
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
Treatment
Intradermal injection Restylane Lidocaine
Restylane Lidocaine: Hyaluronic acid based filler
|
|---|---|---|
|
Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek
|
81 percentage of participants
Interval 67.0 to 91.0
|
—
|
SECONDARY outcome
Timeframe: Month 1, Month 3Population: 48 participants at Month 1, 47 participants at Month 3, due to withdrawal. Split-face design: overall 48 participants, with one treated cheek and one cheek as no-treatment control.
Assessed by blinded evaluator
Outcome measures
| Measure |
Split-face: Treatment/No-treatment Control
n=48 cheeks
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
Treatment
n=48 cheeks
Intradermal injection Restylane Lidocaine
Restylane Lidocaine: Hyaluronic acid based filler
|
|---|---|---|
|
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Month 1
|
0 percentage of participants
Interval 0.0 to 0.0
|
96 percentage of participants
Interval 86.0 to 100.0
|
|
Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)
Month 3
|
6 percentage of participants
Interval 1.0 to 18.0
|
83 percentage of participants
Interval 69.0 to 92.0
|
Adverse Events
Split-face: Treatment/No-treatment Control
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Split-face: Treatment/No-treatment Control
n=49 participants at risk
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Worsening of spinal disc herniation
|
2.0%
1/49 • Number of events 1 • 1 year, 7 months
|
Other adverse events
| Measure |
Split-face: Treatment/No-treatment Control
n=49 participants at risk
All participants were randomized to receive treatment in either right or left cheek. The other cheek was a no-treatment control.
|
|---|---|
|
Infections and infestations
Influenza
|
6.1%
3/49 • Number of events 3 • 1 year, 7 months
|
|
Infections and infestations
Nasopharyngitis
|
16.3%
8/49 • Number of events 11 • 1 year, 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place