Trial Outcomes & Findings for Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds (NCT NCT01798498)
NCT ID: NCT01798498
Last Updated: 2025-02-25
Results Overview
The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
COMPLETED
NA
48 participants
From Day 0 to Day 180
2025-02-25
Participant Flow
Participant milestones
| Measure |
Princess® VOLUME
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Princess® VOLUME
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds
Baseline characteristics by cohort
| Measure |
Princess® VOLUME
n=48 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 180Population: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used.
The primary efficacy endpoint was the absolute change in MFWS from Day 0 to Day 180 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Outcome measures
| Measure |
Princess® VOLUME
n=47 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180
|
-1.309 score on a scale
Standard Deviation 0.373
|
SECONDARY outcome
Timeframe: Day 0 to Days 30, 90, and 270Population: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used.
The change in absolute Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 was additionally assessed at Days 30, 90, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Outcome measures
| Measure |
Princess® VOLUME
n=47 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270
change in MFWS at Day 30
|
-1.484 score on a scale
Standard Deviation 0.408
|
|
Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270
change in MFWS at Day 90
|
-1.436 score on a scale
Standard Deviation 0.415
|
|
Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270
change in MFWS at Day 270
|
-1.223 score on a scale
Standard Deviation 0.401
|
SECONDARY outcome
Timeframe: Days 30, 90, 180, and 270Population: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used.
Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Outcome measures
| Measure |
Princess® VOLUME
n=47 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
Improvement of at least 0.5 Scores on the MFWS - day 30
|
47 Participants
|
|
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
Improvement of at least 0.5 Scores on the MFWS - day 90
|
47 Participants
|
|
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
Improvement of at least 0.5 Scores on the MFWS - day 180
|
47 Participants
|
|
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
Improvement of at least 0.5 Scores on the MFWS - day 270
|
47 Participants
|
SECONDARY outcome
Timeframe: Days 30, 90, 180, and 270Population: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once. The mean of both measurements (right/left nasolabial fold) is used.
Subject satisfaction at Days 30, 90, 180, and 270 To assess subject's satisfaction, subjects were asked to indicate their level of satisfaction on 3- or 5-point scales as follows: * Question 1: How would you judge the change of your appearance after treatment (asked at Days 30, 90, 180, and 270): 1. Very much improved 2. Much improved 3. Slightly improved 4. No change 5. Worsened * Question 2: How satisfied are you with the treatment (to be asked at Days 30 and 270): 1. Very satisfied 2. Satisfied 3. Not satisfied * Question 3: Would you recommend the treatment to your friends and acquaintances (to be asked at Days 30 and 270): 1. Yes 2. Perhaps 3. No
Outcome measures
| Measure |
Princess® VOLUME
n=47 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Subject Satisfaction
Day 90 : Q1 - Appearance after treatment - very much improved
|
6 Participants
|
|
Subject Satisfaction
Day 30 : Q3 - Recommendation of treatment - perhaps
|
1 Participants
|
|
Subject Satisfaction
Day 30 : Q3 - Recommendation of treatment - no
|
0 Participants
|
|
Subject Satisfaction
Day 30 : Q1 - Appearance after treatment - very much improved
|
16 Participants
|
|
Subject Satisfaction
Day 30 : Q1 - Appearance after treatment - much improved
|
27 Participants
|
|
Subject Satisfaction
Day 30 : Q1 - Appearance after treatment - sligthly improved
|
4 Participants
|
|
Subject Satisfaction
Day 30 : Q1 - Appearance after treatment - no change
|
0 Participants
|
|
Subject Satisfaction
Day 30 : Q1 - Appearance after treatment - worsened
|
0 Participants
|
|
Subject Satisfaction
Day 30 : Q2 - Satisfaction with treatment - very satisfied
|
42 Participants
|
|
Subject Satisfaction
Day 30 : Q2 - Satisfaction with treatment - satisfied
|
5 Participants
|
|
Subject Satisfaction
Day 30 : Q2 - Satisfaction with treatment - not satisfied
|
0 Participants
|
|
Subject Satisfaction
Day 30 : Q3 - Recommendation of treatment - yes
|
46 Participants
|
|
Subject Satisfaction
Day 90 : Q1 - Appearance after treatment - much improved
|
37 Participants
|
|
Subject Satisfaction
Day 90 : Q1 - Appearance after treatment - sligthly improved
|
4 Participants
|
|
Subject Satisfaction
Day 90 : Q1 - Appearance after treatment - no change
|
0 Participants
|
|
Subject Satisfaction
Day 90 : Q1 - Appearance after treatment - worsened
|
0 Participants
|
|
Subject Satisfaction
Day 180 : Q1 - Appearance after treatment - very much improved
|
2 Participants
|
|
Subject Satisfaction
Day 180 : Q1 - Appearance after treatment - much improved
|
30 Participants
|
|
Subject Satisfaction
Day 180 : Q1 - Appearance after treatment - sligthly improved
|
15 Participants
|
|
Subject Satisfaction
Day 180 : Q1 - Appearance after treatment - no change
|
0 Participants
|
|
Subject Satisfaction
Day 180 : Q1 - Appearance after treatment - worsened
|
0 Participants
|
|
Subject Satisfaction
Day 270 : Q1 - Appearance after treatment - very much improved
|
5 Participants
|
|
Subject Satisfaction
Day 270 : Q1 - Appearance after treatment - much improved
|
25 Participants
|
|
Subject Satisfaction
Day 270 : Q1 - Appearance after treatment - sligthly improved
|
15 Participants
|
|
Subject Satisfaction
Day 270 : Q1 - Appearance after treatment - no change
|
2 Participants
|
|
Subject Satisfaction
Day 270 : Q1 - Appearance after treatment - worsened
|
0 Participants
|
|
Subject Satisfaction
Day 270 : Q2 - Satisfaction with treatment - very satisfied
|
38 Participants
|
|
Subject Satisfaction
Day 270 : Q2 - Satisfaction with treatment - satisfied
|
8 Participants
|
|
Subject Satisfaction
Day 270 : Q2 - Satisfaction with treatment - not satisfied
|
1 Participants
|
|
Subject Satisfaction
Day 270 : Q3 - Recommendation of treatment - yes
|
44 Participants
|
|
Subject Satisfaction
Day 270 : Q3 - Recommendation of treatment - perhaps
|
3 Participants
|
|
Subject Satisfaction
Day 270 : Q3 - Recommendation of treatment - no
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 14, 30, 90, 180, 270Population: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once.The mean of both measurements (right/left nasolabial fold) is used.
Investigator rating of aesthetic improvement based on GAIS The GAIS is a 5-point scale that rates global aesthetic improvement in appearance, compared to pre-treatment, as judged by the investigator. The rating categories were 'worse', 'no change', 'improved', 'much improved', and 'very much improved'.
Outcome measures
| Measure |
Princess® VOLUME
n=48 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - right NLF · no change
|
1 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - right NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - left NLF · very much improved
|
4 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - right NLF · very much improved
|
14 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - right NLF · much improved
|
29 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - right NLF · improved
|
5 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - right NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - right NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - left NLF · very much improved
|
13 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - left NLF · much improved
|
27 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - left NLF · improved
|
8 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - left NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 14 - left NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - right NLF · very much improved
|
14 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - right NLF · much improved
|
32 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - right NLF · improved
|
1 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - right NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - right NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - left NLF · very much improved
|
15 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - left NLF · much improved
|
30 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - left NLF · improved
|
2 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - left NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 30 - left NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - right NLF · very much improved
|
11 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - right NLF · much improved
|
35 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - right NLF · improved
|
1 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - right NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - right NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - left NLF · very much improved
|
11 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - left NLF · much improved
|
33 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - left NLF · improved
|
3 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - left NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 90 - left NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - right NLF · very much improved
|
5 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - right NLF · much improved
|
36 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - right NLF · improved
|
6 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - right NLF · no change
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - right NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - left NLF · very much improved
|
5 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - left NLF · much improved
|
32 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - left NLF · improved
|
9 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - left NLF · no change
|
1 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 180 - left NLF · worse
|
0 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - right NLF · very much improved
|
4 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - right NLF · much improved
|
33 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - right NLF · improved
|
9 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - left NLF · much improved
|
31 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - left NLF · improved
|
11 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - left NLF · no change
|
1 Participants
|
|
Global Aesthetic Improvement Scale (GAIS)
Day 270 - left NLF · worse
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 14, 30, 90, 180, and 270Population: Safety Analysis Set
Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) at Days 14, 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Outcome measures
| Measure |
Princess® VOLUME
n=48 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 0
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 0.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 1
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 1.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 2
|
30 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 2.5
|
16 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - right NLF · Grade 3
|
2 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 0
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 0.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 1
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 1.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 2
|
26 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 2.5
|
19 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 0 - left NLF · Grade 3
|
3 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 0
|
4 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 0.5
|
18 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 1
|
19 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 1.5
|
7 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - right NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 0
|
6 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 0.5
|
11 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 1
|
24 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 1.5
|
7 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 14 - left NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 0
|
4 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 0.5
|
18 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 1
|
22 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 1.5
|
3 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - right NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 0
|
5 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 0.5
|
16 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 1
|
24 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 1.5
|
2 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 30 - left NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 0
|
4 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 0.5
|
15 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 1
|
25 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 1.5
|
3 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - right NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 0
|
4 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 0.5
|
13 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 1
|
27 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 1.5
|
3 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 90 - left NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 0
|
1 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 0.5
|
14 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 1
|
25 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 1.5
|
6 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 2
|
1 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - right NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 0
|
1 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 0.5
|
13 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 1
|
26 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 1.5
|
5 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 2
|
2 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 180 - left NLF · Grade 3
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 0
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 0.5
|
14 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 1
|
20 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 1.5
|
12 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 2.5
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - right NLF · Grade 3
|
1 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 0
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 0.5
|
13 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 1
|
23 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 1.5
|
10 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 2
|
0 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 2.5
|
1 Participants
|
|
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
Day 270 - left NLF · Grade 3
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 30, 90, 180, and 270Population: safety analysis set (SAF) - The SAF included all subjects who received the investigational device at least once.The mean of both measurements (right/left nasolabial fold) is used.
Percentage of subjects with an improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, 180, and 270 The Modified Fitzpatrick Wrinkle Scale (MFWS), an established objective and validated measurement for nasolabial wrinkle severity assessments. The MFWS is a 7-point rating scale ranging from 0 = no wrinkle to 3 = deep wrinkle where grades are defined as follow: Grade Definition 0 No wrinkle: no visible wrinkle, continuous skin line 0.5 Very shallow yet visible wrinkle 1. Fine wrinkle: visible wrinkle and slight indentation 1.5 Visible wrinkle and clear indentation, \<1 mm wrinkle depth 2. Moderate wrinkle: clear visible wrinkle 1 - 2 mm wrinkle 2.5 Prominent and visible wrinkle: more than 2 mm and less than 3 mm wrinkle depth 3. Deep wrinkle: deep and furrow wrinkle; more than 3 mm wrinkle depth
Outcome measures
| Measure |
Princess® VOLUME
n=47 Participants
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 0.5 both NLFs
|
47 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 1.0 one NLF
|
46 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 1.0 both NLFs
|
46 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 1.5 one NLF
|
36 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 1.5 both NLFs
|
29 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 2.0 one NLF
|
15 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 30 : 2.0 both NLFs
|
10 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 0.5 both NLFs
|
47 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 1.0 one NLF
|
46 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 1.0 both NLFs
|
45 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 1.5 one NLF
|
33 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 1.5 both NLFs
|
27 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 2.0 one NLF
|
14 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 90 : 2.0 both NLFs
|
9 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 0.5 both NLFs
|
47 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 1.0 one NLF
|
45 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 1.0 both NLFs
|
42 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 1.5 one NLF
|
30 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 1.5 both NLFs
|
22 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 2.0 one NLF
|
10 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 180 : 2.0 both NLFs
|
3 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 0.5 both NLFs
|
46 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 1.0 one NLF
|
43 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 1.0 both NLFs
|
40 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 1.5 one NLF
|
26 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 1.5 both NLFs
|
19 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 2.0 one NLF
|
7 Participants
|
|
Improvement in MFWS in One or Both Nasolabial Folds Over Time
Day 270 : 2.0 both NLFs
|
2 Participants
|
Adverse Events
Princess® VOLUME
Serious adverse events
| Measure |
Princess® VOLUME
n=48 participants at risk
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterin Polyp
|
2.1%
1/48
|
Other adverse events
| Measure |
Princess® VOLUME
n=48 participants at risk
Subjects received one injection of the investigational device to both nasolabial folds on Day 0. After the initial treatment, a touch-up treatment was permitted on Day 14, if full correction of the wrinkle had not been achieved with the baseline treatment.
The volume of application depended on the depth of wrinkle to be corrected and was chosen by the investigator.
|
|---|---|
|
General disorders
Hematoma
|
18.8%
9/48 • Number of events 9
|
|
General disorders
bruising
|
6.2%
3/48 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place