Nasolabial Folds
Conditions
Brief summary
The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.
Interventions
DEVICEPrincess® VOLUME
Sponsors
FGK Clinical Research GmbH
Croma-Pharma GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: * Male or female subjects between 30 years and 65 years * Wrinkle score of at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS) Major
Exclusion criteria
* For females: pregnancy, lactating, planned pregnancy or unwilling to use contraceptives * History of allergic reaction to hyaluronic acid products * Facial surgery or implantation of dermal fillers in the nasolabial region within the last 24 months * Skin of the nasolabial region affected by cosmetic treatments (e.g. laser therapy within the last 12 months, chemical peeling within the last 3 months, dermabrasion within the last 12 months, botulinum toxin within the last 12 months ) * Connective tissue diseases * Diabetes mellitus or uncontrolled systemic diseases * Known human immune deficiency virus-positive individuals * Presence of silicone implant or another non-absorbable substance (permanent fillers) in the area of product application * Cutaneous lesions in the evaluated area * Tendency to keloid formation and/or hypertrophic scars * Autoimmune disease * History of allergies against cosmetic filling products and re-current herpes simplex * History of immune system degradation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 | From Day 0 to Day 180 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270 | Day 0 to Days 30, 90, and 270 | 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 |
| Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) | Days 30, 90, 180, and 270 | 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 |
| Subject Satisfaction | Days 30, 90, 180, and 270 | 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 |
| Global Aesthetic Improvement Scale (GAIS) | Days 14, 30, 90, 180, 270 | 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'. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 to Day 14, 30, 90, 180, and 270 | 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 |
| Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 0 to Day 30, 90, 180, and 270 | 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 |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Princess® VOLUME |
|---|---|
| Age, Continuous | 52 years |
| Region of Enrollment Austria | 48 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 48 |
| serious Total, serious adverse events | 1 / 48 |
Outcome results
Primary
Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180
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
Time frame: From Day 0 to Day 180
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Princess® VOLUME | Change in Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Day 180 | -1.309 score on a scale | Standard Deviation 0.373 |
Secondary
Change in the Modified Fitzpatrick Wrinkle Scale (MFWS) From Day 0 to Days 30, 90, and 270
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
Time frame: Day 0 to Days 30, 90, and 270
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Princess® VOLUME | 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 |
| Princess® VOLUME | 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 |
| Princess® VOLUME | 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
Global Aesthetic Improvement Scale (GAIS)
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'.
Time frame: Days 14, 30, 90, 180, 270
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - left NLF | no change | 1 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - left NLF | very much improved | 11 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - right NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - right NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - right NLF | very much improved | 14 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - right NLF | much improved | 29 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - right NLF | improved | 5 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - right NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - right NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - left NLF | very much improved | 13 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - left NLF | much improved | 27 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - left NLF | improved | 8 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - left NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 14 - left NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - right NLF | very much improved | 14 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - right NLF | much improved | 32 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - right NLF | improved | 1 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - right NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - right NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - left NLF | very much improved | 15 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - left NLF | much improved | 30 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - left NLF | improved | 2 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - left NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 30 - left NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - right NLF | very much improved | 11 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - right NLF | much improved | 35 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - right NLF | improved | 1 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - left NLF | much improved | 33 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - left NLF | improved | 3 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - left NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 90 - left NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - right NLF | very much improved | 5 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - right NLF | much improved | 36 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - right NLF | improved | 6 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - right NLF | no change | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - right NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - left NLF | very much improved | 5 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - left NLF | much improved | 32 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - left NLF | improved | 9 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 180 - left NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - right NLF | very much improved | 4 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - right NLF | much improved | 33 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - right NLF | improved | 9 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - right NLF | no change | 1 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - right NLF | worse | 0 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - left NLF | very much improved | 4 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - left NLF | much improved | 31 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - left NLF | improved | 11 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - left NLF | no change | 1 Participants |
| Princess® VOLUME | Global Aesthetic Improvement Scale (GAIS) | Day 270 - left NLF | worse | 0 Participants |
Secondary
Percentage of Subjects With an Improvement of at Least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS)
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
Time frame: Days 30, 90, 180, and 270
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME | 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 |
| Princess® VOLUME | 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 |
| Princess® VOLUME | 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 |
| Princess® VOLUME | 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
Subject Satisfaction
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
Time frame: Days 30, 90, 180, and 270
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q1 - Appearance after treatment - very much improved | 16 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q1 - Appearance after treatment - much improved | 27 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q1 - Appearance after treatment - sligthly improved | 4 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q1 - Appearance after treatment - no change | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q1 - Appearance after treatment - worsened | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q2 - Satisfaction with treatment - very satisfied | 42 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q2 - Satisfaction with treatment - satisfied | 5 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q2 - Satisfaction with treatment - not satisfied | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q3 - Recommendation of treatment - yes | 46 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q3 - Recommendation of treatment - perhaps | 1 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 30 : Q3 - Recommendation of treatment - no | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 90 : Q1 - Appearance after treatment - very much improved | 6 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 90 : Q1 - Appearance after treatment - much improved | 37 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 90 : Q1 - Appearance after treatment - sligthly improved | 4 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 90 : Q1 - Appearance after treatment - no change | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 90 : Q1 - Appearance after treatment - worsened | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 180 : Q1 - Appearance after treatment - very much improved | 2 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 180 : Q1 - Appearance after treatment - much improved | 30 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 180 : Q1 - Appearance after treatment - sligthly improved | 15 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 180 : Q1 - Appearance after treatment - no change | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 180 : Q1 - Appearance after treatment - worsened | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q1 - Appearance after treatment - very much improved | 5 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q1 - Appearance after treatment - much improved | 25 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q1 - Appearance after treatment - sligthly improved | 15 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q1 - Appearance after treatment - no change | 2 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q1 - Appearance after treatment - worsened | 0 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q2 - Satisfaction with treatment - very satisfied | 38 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q2 - Satisfaction with treatment - satisfied | 8 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q2 - Satisfaction with treatment - not satisfied | 1 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q3 - Recommendation of treatment - yes | 44 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q3 - Recommendation of treatment - perhaps | 3 Participants |
| Princess® VOLUME | Subject Satisfaction | Day 270 : Q3 - Recommendation of treatment - no | 0 Participants |
Other Pre-specified
Improvement in MFWS in One or Both Nasolabial Folds Over Time
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
Time frame: Day 0 to Day 30, 90, 180, and 270
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 0.5 both NLFs | 47 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 1.0 one NLF | 46 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 1.0 both NLFs | 46 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 1.5 one NLF | 36 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 1.5 both NLFs | 29 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 2.0 one NLF | 15 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 30 : 2.0 both NLFs | 10 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 0.5 both NLFs | 47 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 1.0 one NLF | 46 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 1.0 both NLFs | 45 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 1.5 one NLF | 33 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 1.5 both NLFs | 27 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 2.0 one NLF | 14 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 90 : 2.0 both NLFs | 9 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 0.5 both NLFs | 47 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 1.0 one NLF | 45 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 1.0 both NLFs | 42 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 1.5 one NLF | 30 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 1.5 both NLFs | 22 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 2.0 one NLF | 10 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 180 : 2.0 both NLFs | 3 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 0.5 both NLFs | 46 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 1.0 one NLF | 43 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 1.0 both NLFs | 40 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 1.5 one NLF | 26 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 1.5 both NLFs | 19 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 2.0 one NLF | 7 Participants |
| Princess® VOLUME | Improvement in MFWS in One or Both Nasolabial Folds Over Time | Day 270 : 2.0 both NLFs | 2 Participants |
Other Pre-specified
Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day
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
Time frame: Day 0 to Day 14, 30, 90, 180, and 270
Population: Safety Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 0 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 0.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 1 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 1.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 2 | 30 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 2.5 | 16 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - right NLF | Grade 3 | 2 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 0 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 0.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 1 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 1.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 2 | 26 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 2.5 | 19 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 0 - left NLF | Grade 3 | 3 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 0 | 4 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 0.5 | 18 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 1 | 19 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 1.5 | 7 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - right NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 0 | 6 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 0.5 | 11 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 1 | 24 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 1.5 | 7 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 14 - left NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 0 | 4 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 0.5 | 18 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 1 | 22 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 1.5 | 3 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - right NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 0 | 5 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 0.5 | 16 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 1 | 24 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 1.5 | 2 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 30 - left NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 0 | 4 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 0.5 | 15 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 1 | 25 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 1.5 | 3 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - right NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 0 | 4 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 0.5 | 13 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 1 | 27 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 1.5 | 3 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 90 - left NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 0 | 1 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 0.5 | 14 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 1 | 25 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 1.5 | 6 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 2 | 1 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - right NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 0 | 1 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 0.5 | 13 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 1 | 26 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 1.5 | 5 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 2 | 2 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 180 - left NLF | Grade 3 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 0 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 0.5 | 14 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 1 | 20 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 1.5 | 12 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 2.5 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - right NLF | Grade 3 | 1 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 0 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 0.5 | 13 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 1 | 23 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 1.5 | 10 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 2 | 0 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 2.5 | 1 Participants |
| Princess® VOLUME | Modified Fitzpatrick Wrinkle Scale (MFWS) Grades Per Day | Day 270 - left NLF | Grade 3 | 0 Participants |