Trial Outcomes & Findings for Restylane-L for Correction of Infraorbital Hollows (NCT NCT04154930)
NCT ID: NCT04154930
Last Updated: 2023-04-25
Results Overview
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
333 participants
Primary outcome timeframe
At 3 months after Baseline
Results posted on
2023-04-25
Participant Flow
The study was conducted at 16 sites in the United States from 11 November 2019 to 06 April 2022.
Participant milestones
| Measure |
Restylane-L® Treatment
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Overall Study
STARTED
|
287
|
46
|
|
Overall Study
COMPLETED
|
250
|
33
|
|
Overall Study
NOT COMPLETED
|
37
|
13
|
Reasons for withdrawal
| Measure |
Restylane-L® Treatment
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
6
|
|
Overall Study
Withdrew consent- Covid-19 related
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
6
|
|
Overall Study
Other
|
6
|
0
|
Baseline Characteristics
Restylane-L for Correction of Infraorbital Hollows
Baseline characteristics by cohort
| Measure |
Restylane-L® Treatment
n=287 Participants
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=46 Participants
No-treatment control group did not receive any treatment during the main study period.
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 11.58 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 12.27 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
221 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White · White
|
257 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White · Black or African American
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White · Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White · Other
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST I
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST II
|
75 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST III
|
117 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST IV
|
62 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST V
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Fitzpatrick skin type (FST)
FST VI
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - left
0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - left
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - left
2
|
147 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - left
3
|
140 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - right
0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - right
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - right
2
|
147 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Blinded Evaluator GIHS score - right
3
|
140 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 3 months after BaselinePopulation: The modified intention-to-treat (mITT) population included all participants who were randomized and analyzed according to the randomization scheme and who did not have a GIHS Month 3 visit assessment conducted remotely (i.e., remote study visit and/or GIHS assessment performed remotely).
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
Outcome measures
| Measure |
Restylane-L® Treatment
n=210 Participants
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=35 Participants
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)
|
87.4 Percentage of participants
|
17.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatmentPopulation: mITT population included all participants who were randomized and analyzed according to the randomization scheme and who did not have a GIHS Month 3 visit assessment conducted remotely (that is \[i.e.\], remote study visits and/or GIHS assessment performed remotely). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints.
Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the GIHS, on both sides of the face, concurrently at each of the timepoints. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
Outcome measures
| Measure |
Restylane-L® Treatment
n=257 Participants
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=37 Participants
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
At Month 6
|
86.0 Percentage of participants
|
13.5 Percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
At Month 9
|
77.6 Percentage of participants
|
11.1 Percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
At Month 12
|
63.5 Percentage of participants
|
11.1 Percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
At Month 3 after optional treatment
|
87.1 Percentage of participants
|
82.8 Percentage of participants
|
|
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
At Month 6 after optional treatment
|
80.3 Percentage of participants
|
65.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatmentPopulation: ITT population included all participants who were randomized and analyzed according to the randomization scheme. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints.
GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of your tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Outcome measures
| Measure |
Restylane-L® Treatment
n=272 Participants
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=38 Participants
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 1
|
93.0 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 3
|
95.0 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 6
|
91.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 9
|
88.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 12
|
79.8 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 1 after optional touch up
|
99.0 Percentage of participants
|
—
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 1 after optional treatment
|
98.7 Percentage of participants
|
93.8 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 3 after optional treatment
|
94.3 Percentage of participants
|
89.7 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Month 6 after optional treatment
|
93.0 Percentage of participants
|
82.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatmentPopulation: ITT population included all participants who were randomized and analyzed according to the randomization scheme. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given timepoints.
GAIS responder rates are based on independent assessments by the Treating Investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the treating investigator to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of participant's tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
Outcome measures
| Measure |
Restylane-L® Treatment
n=271 Participants
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=39 Participants
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 1
|
97.4 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 3
|
97.7 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 6
|
95.3 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 9
|
92.5 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 12
|
87.5 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 1 after optional touch up
|
99.5 Percentage of participants
|
—
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 1 after optional treatment
|
100 Percentage of participants
|
100 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 3 after optional treatment
|
97.4 Percentage of participants
|
96.6 Percentage of participants
|
|
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
At Month 6 after optional treatment
|
99.4 Percentage of participants
|
89.7 Percentage of participants
|
Adverse Events
Restylane-L® Treatment
Serious events: 4 serious events
Other events: 97 other events
Deaths: 1 deaths
No Treatment Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane-L® Treatment
n=287 participants at risk
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=46 participants at risk
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Infections and infestations
COVID 19
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
Other adverse events
| Measure |
Restylane-L® Treatment
n=287 participants at risk
Participants were injected with Restylane-L® intradermal injection using either needle or cannula on Day 1, optional touch-up injection administered at 1 month of initial treatment.
|
No Treatment Control
n=46 participants at risk
No-treatment control group did not receive any treatment during the main study period.
|
|---|---|---|
|
Nervous system disorders
Migraine
|
1.0%
3/287 • Number of events 3 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
2.2%
1/46 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
COVID 19
|
5.2%
15/287 • Number of events 15 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
2.2%
1/46 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Vascular disorders
Hypertension
|
0.00%
0/287 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
2.2%
1/46 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Influenza
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
2.2%
1/46 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/287 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
2.2%
1/46 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/287 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
2.2%
1/46 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Nervous system disorders
Headache
|
10.5%
30/287 • Number of events 30 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Pneumonia
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Otitis Media
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.7%
5/287 • Number of events 8 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Hordeolum
|
1.0%
3/287 • Number of events 3 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
6/287 • Number of events 6 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Metabolism and nutrition disorders
Diabetes
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Psychiatric disorders
Bipolar Disorder II
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Nervous system disorders
Hypoaesthesia
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Immune system disorders
COVID 19 Vaccine reaction
|
1.4%
4/287 • Number of events 11 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Gastrointestinal disorders
Stomachache
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Gastrointestinal disorders
Nausea
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Immune system disorders
Seasonal Allergy
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Immune system disorders
Upper Respiratory Infection
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Ear infection
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Bronchitis
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Musculoskeletal and connective tissue disorders
Herniated disk
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Product Issues
Spontaneous Breast Implant Rupture
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Psychiatric disorders
ADHD
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Sinusitis
|
1.0%
3/287 • Number of events 3 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Vascular disorders
Varicose vein
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Metabolism and nutrition disorders
Glucose Tolerance Impaired
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Pyrexia
|
1.7%
5/287 • Number of events 6 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Gastrointestinal disorders
Colitis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Urinary tract infection
|
1.7%
5/287 • Number of events 5 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Nervous system disorders
Dizziness
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Nervous system disorders
Epistaxis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Reproductive system and breast disorders
Endometriosis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Eye disorders
Dysplastic naevus
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
acne
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Reproductive system and breast disorders
polycystic ovary syndrome
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Nervous system disorders
Sciatica
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Lupus erythematosus
|
0.70%
2/287 • Number of events 3 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Gastrointestinal disorders
Diarrhea
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Viral rhinitis
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Injury due to fall
|
0.35%
1/287 • Number of events 3 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Strep throat
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Vulval abcess
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Injury, poisoning and procedural complications
Contusion
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Psychiatric disorders
Binge drinking
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumor
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Fatigue
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mass in right breast
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Eye disorders
Photophobia
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Immune system disorders
Autoimmune Disorder
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Nervous system disorders
Syncope
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Infections and infestations
Tinea Pedis
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Swelling
|
4.2%
12/287 • Number of events 26 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Pain
|
2.8%
8/287 • Number of events 13 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Bruising
|
1.7%
5/287 • Number of events 7 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Mass
|
1.4%
4/287 • Number of events 4 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Oedema
|
1.4%
4/287 • Number of events 7 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Pruritus
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Discolouration
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Skin Discolouration
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Induration
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
General disorders
Implant Site Paraesthesia
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Post Inflammatory Pigmentation Change
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.35%
1/287 • Number of events 1 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
|
Skin and subcutaneous tissue disorders
Skin Dryness
|
0.70%
2/287 • Number of events 2 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
0.00%
0/46 • From randomization up to 18 months
Safety population includes all subjects who were treated with Restylane-L or randomized to the control group
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER