Nasolabial Fold, Hypoplastic
Conditions
Brief summary
In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator.
Detailed description
This is a prospective, open label, multicenter, post-market investigation. Following informed consent and screening, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® VOLUME Lidocaine, and will return for follow-up assessments 2, 4, 24 and 36 weeks after the treatment. A Touch-up treatment may be done at Week 2, if deemed appropriate by the investigator. The performance of the investigational device will be evaluated by the investigator by assessing severity of nasolabial folds using the Nasolabial Folds Severity Rating Scale (NLF-SRS) (4, 24 and 36 weeks after the treatment and in comparison to Day 0), global aesthetic improvement (4, 24 and 36 weeks after the treatment). The subject will evaluate pain intensity associated with the treatment (at Day 0 and at Week 2 (if Touch-up treatment occurred)), and satisfaction with the treatment 4, 24 and 36 weeks after the treatment. The safety will be evaluated based on occurrence of adverse events, which will be collected throughout the investigation.
Interventions
DEVICEPrincess® VOLUME Lidocaine
Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
Sponsors
Croma-Pharma GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Princess® VOLUME Lidocaine for the correction of nasolabial folds
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 years of age or older 2. Presence of two fully visible, approximately symmetrical nasolabial folds, with each of the folds scored 2-3 according to the 5-grade Nasolabial Folds Severity Rating Scale (NLF-SRS) as assessed by the investigator 3. Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation 4. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation 5. Written signed and dated informed consent
Exclusion criteria
1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only) 2. History of mental disorders or emotional instability 3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic 4. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region 5. Facial surgery or implantation of dermal fillers, absorbable and nonabsorbable sutures (thread), laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous 12 months, or chemical peeling within previous 3 months, or planning to undergo such procedures in the treatment area during the study 6. Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region 7. Cutaneous lesions in the treatment area 8. Known human immune deficiency virus-positive individuals 9. History of allergies against aesthetic filling products and recurrent herpes simplex 10. Tendency to hypertrophic scars and/or keloid formation 11. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy 12. Diabetes mellitus or uncontrolled systemic diseases 13. Use of anticoagulant, antiplatelet or thrombolytic medication from 10 days pre- to 3 days post injection 14. Any medical condition which, in the investigator's opinion. prohibits the inclusion in the study 15. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study 16. Previous enrolment in this clinical investigation 17. Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NLF-SRS Grade of Nasolabial Folds Reduction | 24 weeks | 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 |
| NLF-SRS Grade of Nasolabial Folds Change | 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints | week 4, week 36 | The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 4 and week 36 versus baseline |
| Aesthetic Improvement | week 4, week 24, week 36 | 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) |
| Pain Intensity | Day 1, Day 15 | 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). |
| NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer | Week 24 | 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. |
| Subjects' Satisfaction With Aesthetic Outcome | week 4, week 24, week 36 | Subjects' satisfaction rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject |
| NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints | Week 4, Week 36 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Events | From day 0 until patient last visit / week 36 | Occurrence and frequency of adverse events |
Countries
Austria
Participant flow
Recruitment details
62 subjects were screened and enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Princess® VOLUME Lidocaine |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Region of Enrollment Austria | 62 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 12 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
NLF-SRS Grade of Nasolabial Folds Change
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
Time frame: 24 weeks
Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Change | -1.50 score on a scale | Standard Deviation 0.58 |
Primary
NLF-SRS Grade of Nasolabial Folds Reduction
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
Time frame: 24 weeks
Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Reduction | 58 Participants |
Secondary
Aesthetic Improvement
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)
Time frame: week 4, week 24, week 36
Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME Lidocaine | Aesthetic Improvement | Week 4 | 61 Participants |
| Princess® VOLUME Lidocaine | Aesthetic Improvement | Week 24 | 58 Participants |
| Princess® VOLUME Lidocaine | Aesthetic Improvement | Week 36 | 58 Participants |
Secondary
NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints
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
Time frame: Week 4, Week 36
Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints | Week 4 | -1.54 score on a scale | Standard Deviation 0.62 |
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Change - Other Timepoints | Week 36 | -1.35 score on a scale | Standard Deviation 0.66 |
Secondary
NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer
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.
Time frame: Week 24
Population: ITT- Intent to treat population - As defined in the Baseline Analysis Population Description
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Reduction- Imaging Independent Reviewer | 60 Participants |
Secondary
NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints
The proportion of subjects with the NLF-SRS grade reduced by ≥1 point at week 4 and week 36 versus baseline
Time frame: week 4, week 36
Population: ITT - Intent to treat Population - as defined in Baseline Analysis Population Description
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints | Week 4 | 58 Participants |
| Princess® VOLUME Lidocaine | NLF-SRS Grade of Nasolabial Folds Reduction- Other Timepoints | Week 36 | 54 Participants |
Secondary
Pain Intensity
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).
Time frame: Day 1, Day 15
Population: ITT - Intent to treat Population - defined in Baseline Analysis Population Description
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Princess® VOLUME Lidocaine | Pain Intensity | Baseline- Initial Assessment (right after injection) | 1.2 score on a scale | Standard Deviation 1.3 |
| Princess® VOLUME Lidocaine | Pain Intensity | Baseline - Second Assessment ( 15 min after injection) | 0.1 score on a scale | Standard Deviation 0.4 |
| Princess® VOLUME Lidocaine | Pain Intensity | Baseline - Change from initial assessment to second assessment | -1.0 score on a scale | Standard Deviation 1.1 |
| Princess® VOLUME Lidocaine | Pain Intensity | Week 2 /Touch up - Initial Assessment (right after injection) | 1.5 score on a scale | Standard Deviation 0.9 |
| Princess® VOLUME Lidocaine | Pain Intensity | Week 2 /Touch up - Second Assessment ( 15 min after injection) | 0.0 score on a scale | Standard Deviation 0 |
| Princess® VOLUME Lidocaine | Pain Intensity | Week 2/ touch up - Change from initial assessment to second assessment | -1.5 score on a scale | Standard Deviation 0.9 |
Secondary
Subjects' Satisfaction With Aesthetic Outcome
Subjects' satisfaction rate with aesthetic outcome of the treatment at Week 4, Week 24 and Week 36, as evaluated by the subject
Time frame: week 4, week 24, week 36
Population: 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'.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME Lidocaine | Subjects' Satisfaction With Aesthetic Outcome | Week 4 | 52 Participants |
| Princess® VOLUME Lidocaine | Subjects' Satisfaction With Aesthetic Outcome | Week 24 | 48 Participants |
| Princess® VOLUME Lidocaine | Subjects' Satisfaction With Aesthetic Outcome | Week 36 | 49 Participants |
Other Pre-specified
Safety Events
Occurrence and frequency of adverse events
Time frame: From day 0 until patient last visit / week 36
Population: SAF - as defined in the Baseline Analysis Population Description
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Princess® VOLUME Lidocaine | Safety Events | Adverse Device Effect - Injection site hematoma | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Adverse Device Effect - Injection site hypoesthesia | 6 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Adverse Device Effect - Injection site pain | 2 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Adverse Device Effect - Syncope | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Influenza | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Lice Infestation | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Rhinitis | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Urinary tract infection | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Ligament sprain | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Synovitis | 1 Participants |
| Princess® VOLUME Lidocaine | Safety Events | Polyneuropathy | 1 Participants |