Trial Outcomes & Findings for Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF) (NCT NCT03990883)
NCT ID: NCT03990883
Last Updated: 2025-02-04
Results Overview
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence.
COMPLETED
NA
295 participants
Week 24
2025-02-04
Participant Flow
Of 295 enrolled participants, 270 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the left side of the face.
Comparator: Injection into the nasolabial fold on the right side of the face.
|
Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the right side of the face.
Comparator: Injection into the nasolabial fold on the left side of the face.
|
Princess Filler Lidocaine Open Label Extension
Princess Filler Lidocaine Open Label Extension where all subjects from Arm 1 and 2 can receive Experimental Treatment to both right and left nasolabial folds.
Princess Filler Lidocaine: Injection into nasolabial folds on both sides of the face.
|
|---|---|---|---|
|
Blinded Treatment Phase
STARTED
|
136
|
134
|
0
|
|
Blinded Treatment Phase
COMPLETED
|
113
|
111
|
0
|
|
Blinded Treatment Phase
NOT COMPLETED
|
23
|
23
|
0
|
|
Open Label Extension Phase
STARTED
|
0
|
0
|
48
|
|
Open Label Extension Phase
COMPLETED
|
0
|
0
|
46
|
|
Open Label Extension Phase
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the left side of the face.
Comparator: Injection into the nasolabial fold on the right side of the face.
|
Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the right side of the face.
Comparator: Injection into the nasolabial fold on the left side of the face.
|
Princess Filler Lidocaine Open Label Extension
Princess Filler Lidocaine Open Label Extension where all subjects from Arm 1 and 2 can receive Experimental Treatment to both right and left nasolabial folds.
Princess Filler Lidocaine: Injection into nasolabial folds on both sides of the face.
|
|---|---|---|---|
|
Blinded Treatment Phase
Adverse Event
|
1
|
1
|
0
|
|
Blinded Treatment Phase
Lost to Follow-up
|
7
|
10
|
0
|
|
Blinded Treatment Phase
Physician Decision
|
1
|
0
|
0
|
|
Blinded Treatment Phase
Withdrawal by Subject
|
2
|
5
|
0
|
|
Blinded Treatment Phase
COVID-19
|
3
|
2
|
0
|
|
Blinded Treatment Phase
Personal Reasons
|
6
|
3
|
0
|
|
Blinded Treatment Phase
Temporary Hold on Repeat Treatment
|
3
|
2
|
0
|
|
Open Label Extension Phase
Lost to Follow-up
|
0
|
0
|
1
|
|
Open Label Extension Phase
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)
Baseline characteristics by cohort
| Measure |
Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side
n=136 Participants
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the left side of the face.
Comparator: Injection into the nasolabial fold on the right side of the face.
|
Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side
n=134 Participants
Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the right side of the face.
Comparator: Injection into the nasolabial fold on the left side of the face.
|
Total
n=270 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
|
107 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 9.65 • n=99 Participants
|
55.0 years
STANDARD_DEVIATION 9.08 • n=107 Participants
|
55.4 years
STANDARD_DEVIATION 9.37 • n=206 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
264 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
210 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (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
|
136 participants
n=99 Participants
|
134 participants
n=107 Participants
|
270 participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type I
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type II
|
36 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type III
|
41 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type V
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Left Side of Face · Grade 0 - none/minimal
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Left Side of Face · Grade 1 - mild
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Left Side of Face · Grade 2 - moderate
|
56 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Left Side of Face · Grade 3 - severe
|
80 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Left Side of Face · Grade 4 - extreme
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Right Side of Face · Grade 0 - none/minimal
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Right Side of Face · Grade 1 - mild
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Right Side of Face · Grade 2 - moderate
|
61 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Right Side of Face · Grade 3 - severe
|
75 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
158 Participants
n=206 Participants
|
|
Nasolabial Folds-Severity Rating Scale (NLF-SRS)
NLF-SRS Right Side of Face · Grade 4 - extreme
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized.
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence.
Outcome measures
| Measure |
Princess Filler Lidocaine
n=270 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=270 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset
|
222 Participants
|
221 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized.
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025).
Outcome measures
| Measure |
Princess Filler Lidocaine
n=224 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=224 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset
|
187 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized.
The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025).
Outcome measures
| Measure |
Princess Filler Lidocaine
n=270 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=270 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset
|
165 Participants
|
173 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized.
The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025).
Outcome measures
| Measure |
Princess Filler Lidocaine
n=224 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=224 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset
|
145 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized.
The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025).
Outcome measures
| Measure |
Princess Filler Lidocaine
n=270 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=270 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set
|
225 Participants
|
226 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized.
The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025).
Outcome measures
| Measure |
Princess Filler Lidocaine
n=224 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=224 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set
|
194 Participants
|
195 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. Only participants with available data were included in the analysis.
The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Outcome measures
| Measure |
Princess Filler Lidocaine
n=249 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=249 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24
|
232 Participants
|
231 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. Only participants with available data were included in the analysis.
The percentage of subjects with an improvement over Baseline (subjects who have been rated as "very much improved" or "much improved" or "improved"), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as "very much improved", "much improved", "improved", "no change", and "worse".
Outcome measures
| Measure |
Princess Filler Lidocaine
n=250 Participants
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Comparator
n=249 Participants
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
|---|---|---|
|
Improvement Over Baseline Based on Subject Assessment at Week 24
|
229 Participants
|
228 Participants
|
Adverse Events
Blinded Period: Princess Filler Lidocaine
Blinded Period: Comparator
Open Label Extension Period: Princess Filler Lidocaine
Serious adverse events
| Measure |
Blinded Period: Princess Filler Lidocaine
n=270 participants at risk
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Blinded Period: Comparator
n=270 participants at risk
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
Open Label Extension Period: Princess Filler Lidocaine
n=48 participants at risk
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on the left and the right side of the face.
|
|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Vascular disorders
Vascular compression
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/270 • Up to 60 weeks
|
0.00%
0/270 • Up to 60 weeks
|
2.1%
1/48 • Number of events 1 • Up to 60 weeks
|
Other adverse events
| Measure |
Blinded Period: Princess Filler Lidocaine
n=270 participants at risk
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on either the left or the right side of the face.
|
Blinded Period: Comparator
n=270 participants at risk
Treatment with Comparator: Injection into the nasolabial fold on either the right or the left side of the face.
|
Open Label Extension Period: Princess Filler Lidocaine
n=48 participants at risk
Treatment with Princess Filler Lidocaine: Injection into the nasolabial fold on the left and the right side of the face.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.9%
5/270 • Number of events 5 • Up to 60 weeks
|
1.9%
5/270 • Number of events 5 • Up to 60 weeks
|
4.2%
2/48 • Number of events 2 • Up to 60 weeks
|
|
Nervous system disorders
Headache
|
4.4%
12/270 • Number of events 17 • Up to 60 weeks
|
4.4%
12/270 • Number of events 17 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Nervous system disorders
Dizziness
|
1.1%
3/270 • Number of events 3 • Up to 60 weeks
|
1.1%
3/270 • Number of events 3 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
General disorders
Swelling
|
1.5%
4/270 • Number of events 4 • Up to 60 weeks
|
0.74%
2/270 • Number of events 2 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
General disorders
Discomfort
|
1.1%
3/270 • Number of events 4 • Up to 60 weeks
|
1.1%
3/270 • Number of events 3 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
General disorders
Injection site erythema
|
1.1%
3/270 • Number of events 3 • Up to 60 weeks
|
0.37%
1/270 • Number of events 1 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.5%
4/270 • Number of events 4 • Up to 60 weeks
|
1.5%
4/270 • Number of events 4 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Eye disorders
Eyelid margin crusting
|
2.2%
6/270 • Number of events 7 • Up to 60 weeks
|
2.2%
6/270 • Number of events 7 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
4/270 • Number of events 4 • Up to 60 weeks
|
1.5%
4/270 • Number of events 5 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
3/270 • Number of events 4 • Up to 60 weeks
|
1.1%
3/270 • Number of events 4 • Up to 60 weeks
|
0.00%
0/48 • Up to 60 weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/270 • Up to 60 weeks
|
0.00%
0/270 • Up to 60 weeks
|
2.1%
1/48 • Number of events 1 • Up to 60 weeks
|
Additional Information
Clinical Development - Head of Clinical Operations
Croma Pharma GmbH
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place