Trial Outcomes & Findings for Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds (NCT NCT03050710)
NCT ID: NCT03050710
Last Updated: 2025-06-04
Results Overview
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
COMPLETED
NA
62 participants
24 weeks
2025-06-04
Participant Flow
62 subjects were screened and enrolled.
Participant milestones
| Measure |
Princess® VOLUME Lidocaine
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds
Baseline characteristics by cohort
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
62 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
Austria
|
62 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=61 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
NLF-SRS Grade of Nasolabial Folds Change
|
-1.50 score on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 24 versus baseline. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=61 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
NLF-SRS Grade of Nasolabial Folds Reduction
|
58 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 36Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 4 and Week 36 as evaluated by the investigator. The Croma NLF-SRS is a validated, 5-point scale ranging from Grade 0 (none or minimal) to Grade 4 (extreme), therefore a reduction in value, represents an improvement on an aesthetical perspective
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints
Week 36
|
-1.35 score on a scale
Standard Deviation 0.66
|
|
NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints
Week 4
|
-1.54 score on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: week 4, week 36Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 4 and week 36 versus baseline
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints
Week 4
|
58 Participants
|
|
NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints
Week 36
|
54 Participants
|
SECONDARY outcome
Timeframe: week 4, week 24, week 36Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
The proportion of subjects with aesthetic improvement at Week 4, Week 24 and Week 36, as evaluated by the investigator using the Global Aesthetic Improvement Scale (GAIS)
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
Aesthetic Improvement
Week 4
|
61 Participants
|
|
Aesthetic Improvement
Week 24
|
58 Participants
|
|
Aesthetic Improvement
Week 36
|
58 Participants
|
SECONDARY outcome
Timeframe: week 4, week 24, week 36Population: ITT - Intend to Treat Population as defined in the Baseline Analysis Population description. The results below reflect the subjects who rated their satisfaction with the treatment as 'very satisfied'.
Subjects' satisfaction rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
Subjects' Satisfaction With Aesthetic Outcome
Week 4
|
52 Participants
|
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Subjects' Satisfaction With Aesthetic Outcome
Week 24
|
48 Participants
|
|
Subjects' Satisfaction With Aesthetic Outcome
Week 36
|
49 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15Population: ITT - Intent to treat Population - defined in Baseline Analysis Population Description
The average pain intensity during and after the treatment, as evaluated by the subject using an 11-point numeric pain rating scale (NPRS), where 0= no pain and 10 = worst pain imaginable, immediately after the last injection and 15 minutes thereafter. Lower scores represent better outcomes (less pain). Higher scores represent worse outcomes (more pain).
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
Pain Intensity
Baseline- Initial Assessment (right after injection)
|
1.2 score on a scale
Standard Deviation 1.3
|
|
Pain Intensity
Baseline - Second Assessment ( 15 min after injection)
|
0.1 score on a scale
Standard Deviation 0.4
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Pain Intensity
Baseline - Change from initial assessment to second assessment
|
-1.0 score on a scale
Standard Deviation 1.1
|
|
Pain Intensity
Week 2 /Touch up - Initial Assessment (right after injection)
|
1.5 score on a scale
Standard Deviation 0.9
|
|
Pain Intensity
Week 2 /Touch up - Second Assessment ( 15 min after injection)
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Pain Intensity
Week 2/ touch up - Change from initial assessment to second assessment
|
-1.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 24Population: ITT- Intent to treat population - As defined in the Baseline Analysis Population Description
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus Baseline at Week 24 as evaluated by the independent reviewer of photographs.
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=61 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer
|
60 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From day 0 until patient last visit / week 36Population: SAF - as defined in the Baseline Analysis Population Description
Occurrence and frequency of adverse events
Outcome measures
| Measure |
Princess® VOLUME Lidocaine
n=62 Participants
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
Safety Events
Adverse Device Effect - Injection site hematoma
|
1 Participants
|
|
Safety Events
Adverse Device Effect - Injection site hypoesthesia
|
6 Participants
|
|
Safety Events
Adverse Device Effect - Injection site pain
|
2 Participants
|
|
Safety Events
Adverse Device Effect - Syncope
|
1 Participants
|
|
Safety Events
Influenza
|
1 Participants
|
|
Safety Events
Lice Infestation
|
1 Participants
|
|
Safety Events
Rhinitis
|
1 Participants
|
|
Safety Events
Urinary tract infection
|
1 Participants
|
|
Safety Events
Ligament sprain
|
1 Participants
|
|
Safety Events
Synovitis
|
1 Participants
|
|
Safety Events
Polyneuropathy
|
1 Participants
|
Adverse Events
Princess® VOLUME Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Princess® VOLUME Lidocaine
n=62 participants at risk
Princess® VOLUME Lidocaine: Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
|
|---|---|
|
General disorders
injection site hypoaesthesia
|
9.7%
6/62 • Number of events 6 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
General disorders
Injection site pain
|
3.2%
2/62 • Number of events 2 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
General disorders
Injection site haematoma
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
General disorders
pyrexia
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Infections and infestations
urinary tract infection
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Infections and infestations
influenza
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Infections and infestations
lice infestation
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Infections and infestations
rhinitis
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Injury, poisoning and procedural complications
ligament sprain
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Musculoskeletal and connective tissue disorders
synovitis
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Nervous system disorders
polyneuropathy
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
|
Nervous system disorders
syncope
|
1.6%
1/62 • Number of events 1 • 36 weeks - Up to 36 weeks after treatment (Day 0)
AEs will be detected at each visit by clinical examination and by asking the subject about the occurrence of AEs. Care should be taken not to introduce bias when eliciting AE information from the subject. In addition, the subjects will be instructed to immediately contact the investigator/study site in case of occurrence of any untoward event between visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place