Dermatological Non-Disease
Conditions
Keywords
nasolabial folds, correction
Brief summary
Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds
Detailed description
Clinical Investigation to assess the effectiveness of Princess Filler Lidocaine in reducing the severity of nasolabial folds compared to Juvederm Ultra XC, based on the independent blinded evaluating investigator live assessment using the Nasolabial Folds Severity Rating Scale (NLF-SRS) at Week 24 after initial treatment and relative to Baseline assessments
Interventions
correction of nasolabial folds
Sponsors
Syneos Health
Croma-Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
subject- and evaluator-blinded
Intervention model description
Pivotal study
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 22 years of age or older, at the Screening visit 2. Subjects with two fully visible, approximately symmetrical moderate to severe NLFs (same severity) with severity scores of 2 or 3 on the 5- point NLF-SRS for both NLF as judged by the treating investigator in conjunction with the independent blinded evaluating investigator. 3. Females of childbearing potential must have a negative urine pregnancy test at injection visits and must agree to use an adequate method of contraception for the duration of the clinical investigation 4. Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation 5. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation, including botulinum toxin injections (except glabellar or forehead botulinum toxin treatment) 6. Subjects having understood the purpose and conduct of the clinical investigation and having given written informed consent
Exclusion criteria
1. For females: pregnant and/or lactating or planning to become pregnant during the clinical investigation 2. History of allergies or hypersensitivity to HA preparations, lidocaine or anesthetics of any amide-based anesthetic 3. Since Juvéderm® Ultra XC contains trace amounts of Gram-positive bacterial proteins, subjects with history of allergies to such material can not be included in this clinical investigation 4. Tendency to keloid formation, hypertrophic scars and/or pigmentation disorders 5. Known human immune deficiency virus-positive individuals 6. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the area to be treated 7. Re-current herpes simplex in the treatment area 8. History or presence of any autoimmune or connective tissue disease, or current treatment with immunomodulating therapy 9. Uncontrolled (or instable) diabetes mellitus or systemic diseases 10. Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) area of device application 11. Implantation of facial dermal fillers in the treatment area in the preceding twelve months 12. Skin of the nasolabial region affected by aesthetic treatments (e.g. laser therapy, absorbable and non-absorbable sutures (threads), microneedling and/or botulinum toxin within the last twelve months, dermabrasion and mesotherapy within the last six months, chemical peeling within the last three months) or planning to undergo such procedures during the clinical investigation 13. Facial lypolysis, including submental fat treatments, within last month prior to enrollment and during the clinical investigation 14. Bariatric surgery within 12 months prior to enrollement and during the clinical investigation 15. History of bleeding disorders and/or use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection 16. Planned dental/oral surgery or modification (bridge-work, implants) within two weeks prior injection and to a minimum of four weeks post injection 17. Any medical condition prohibiting the inclusion in the clinical investigation according to the judgment of the treating investigator 18. Previous enrollment in this clinical investigation 19. Current participation in another clinical investigation, or treatment with any investigational drug/medical device within 30 days prior to clinical investigation enrollment 20. Any dependency of the subject to the treating investigator, the blinded independent evaluating investigator or clinical investigation site (e.g. employees of the sponsor), or subjects who are employees or relatives of the treating investigator and/or the independent blinded evaluating investigator 21. Subjects who have one of the following assessments during the visual examinations at Baseline: Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test. Repeat Treatment - Inclusion Criteria: 1. In the opinion of the treating investigator, the subject has returned to sufficient severity of both NLFs that would have qualified him for enrollment into the clinical investigation initially (note that the subject does not have to return to his Baseline severity to be permitted to receive a repeat treatment) 2. Subjects with NLFs with severity scores of 2 or 3 on the 5-point NLF-SRS for both NLFs as judged by the treating investigator in conjunction with the independent blinded evaluating investigator (note that it is not necessary for the treating and evaluating investigator to agree on the same rating) 3. Females of childbearing age must have a negative urine pregnancy test at the repeat-treatment visit and must agree to continue to use an adequate method of contraception for the duration of the clinical investigation 4. Healthy skin in the nasolabial area and free of diseases that could interfere in cutaneous aging evaluation and/or injection Repeat Treatment -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset | Week 24 | The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence. |
| Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset | Week 24 | The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set | Week 24 | The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025). |
| Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set | Week 24 | The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025). |
| Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset | Week 24 | The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025). |
| Improvement Over Baseline Based on Subject Assessment at Week 24 | Week 24 | The percentage of subjects with an improvement over Baseline (subjects who have been rated as very much improved or much improved or improved), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as very much improved, much improved, improved, no change, and worse. |
| Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24 | Week 24 | The percentage of subjects with an improvement over Baseline (subjects who have been rated as very much improved or much improved or improved), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as very much improved, much improved, improved, no change, and worse. |
| Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset | Week 24 | The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025). |
Countries
United States
Participant flow
Pre-assignment details
Of 295 enrolled participants, 270 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the left side of the face.
Comparator: Injection into the nasolabial fold on the right side of the face. | 136 |
| Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator.
Princess Filler Lidocaine: Injection into the nasolabial fold on the right side of the face.
Comparator: Injection into the nasolabial fold on the left side of the face. | 134 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Blinded Treatment Phase | Adverse Event | 1 | 1 | 0 |
| Blinded Treatment Phase | COVID-19 | 3 | 2 | 0 |
| Blinded Treatment Phase | Lost to Follow-up | 7 | 10 | 0 |
| Blinded Treatment Phase | Personal Reasons | 6 | 3 | 0 |
| Blinded Treatment Phase | Physician Decision | 1 | 0 | 0 |
| Blinded Treatment Phase | Temporary Hold on Repeat Treatment | 3 | 2 | 0 |
| Blinded Treatment Phase | Withdrawal by Subject | 2 | 5 | 0 |
| Open Label Extension Phase | Lost to Follow-up | 0 | 0 | 1 |
| Open Label Extension Phase | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment With Princess Filler Lidocaine on Left Side, Treatment With Comparator on Right Side | Total | Treatment With Princess Filler Lidocaine on Right Side, Treatment With Comparator on Left Side |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 51 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 219 Participants | 112 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 9.65 | 55.4 years STANDARD_DEVIATION 9.37 | 55.0 years STANDARD_DEVIATION 9.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 60 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107 Participants | 210 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Type I | 9 Participants | 12 Participants | 3 Participants |
| Fitzpatrick Skin Type Type II | 36 Participants | 78 Participants | 42 Participants |
| Fitzpatrick Skin Type Type III | 41 Participants | 81 Participants | 40 Participants |
| Fitzpatrick Skin Type Type IV | 32 Participants | 63 Participants | 31 Participants |
| Fitzpatrick Skin Type Type V | 11 Participants | 21 Participants | 10 Participants |
| Fitzpatrick Skin Type Type VI | 7 Participants | 15 Participants | 8 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Left Side of Face Grade 0 - none/minimal | 0 Participants | 0 Participants | 0 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Left Side of Face Grade 1 - mild | 0 Participants | 0 Participants | 0 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Left Side of Face Grade 2 - moderate | 56 Participants | 104 Participants | 48 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Left Side of Face Grade 3 - severe | 80 Participants | 166 Participants | 86 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Left Side of Face Grade 4 - extreme | 0 Participants | 0 Participants | 0 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Right Side of Face Grade 0 - none/minimal | 0 Participants | 0 Participants | 0 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Right Side of Face Grade 1 - mild | 0 Participants | 0 Participants | 0 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Right Side of Face Grade 2 - moderate | 61 Participants | 112 Participants | 51 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Right Side of Face Grade 3 - severe | 75 Participants | 158 Participants | 83 Participants |
| Nasolabial Folds-Severity Rating Scale (NLF-SRS) NLF-SRS Right Side of Face Grade 4 - extreme | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 29 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 112 Participants | 226 Participants | 114 Participants |
| Region of Enrollment United States | 136 participants | 270 participants | 134 participants |
| Sex: Female, Male Female | 133 Participants | 264 Participants | 131 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 270 | 0 / 270 | 0 / 48 |
| other Total, other adverse events | 38 / 270 | 37 / 270 | 3 / 48 |
| serious Total, serious adverse events | 3 / 270 | 3 / 270 | 1 / 48 |
Outcome results
Primary
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This primary outcome measure is assessed first in a hierarchical testing sequence.
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset | 222 Participants |
| Comparator | Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Full Analysis Dataset | 221 Participants |
p-value: <0.000195% CI: [-2.96, 3.7]McNemar
Primary
Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset
The percentage of responders based on the independent blinded evaluating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the second outcome measure in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first outcome measure achieves statistical significance at the predefined alpha level (0.025).
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset | 187 Participants |
| Comparator | Responder Status Based on Independent Evaluating Investigator Live Assessment at Week 24 - Per Protocol Dataset | 187 Participants |
p-value: <0.000195% CI: [-3.71, 3.71]McNemar
Secondary
Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24
The percentage of subjects with an improvement over Baseline (subjects who have been rated as very much improved or much improved or improved), based on the independent blinded evaluating investigator assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as very much improved, much improved, improved, no change, and worse.
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. Only participants with available data were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24 | 232 Participants |
| Comparator | Improvement Over Baseline Based on Independent Blinded Evaluating Investigator Assessment at Week 24 | 231 Participants |
Secondary
Improvement Over Baseline Based on Subject Assessment at Week 24
The percentage of subjects with an improvement over Baseline (subjects who have been rated as very much improved or much improved or improved), based on subject assessment at Week 24 after initial treatment and using the 5-point Global Aesthetic Improvement Scale (GAIS). GAIS grades are ranked as very much improved, much improved, improved, no change, and worse.
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized. Only participants with available data were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Improvement Over Baseline Based on Subject Assessment at Week 24 | 229 Participants |
| Comparator | Improvement Over Baseline Based on Subject Assessment at Week 24 | 228 Participants |
Secondary
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset
The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the third outcome measure to be analyzed in the hierarchical testing sequence. Statistical significance for this measure will only be assessed if the first and second outcome measures achieve statistical significance at the predefined alpha level (0.025).
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset | 165 Participants |
| Comparator | Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Full Analysis Dataset | 173 Participants |
p-value: 0.02595% CI: [-9.99, 4.07]McNemar
Secondary
Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset
The percentage of responders based on the independent photographic reviewers assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC and based on photographs. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fourth outcome measure in the hierarchical testing sequence. Testing for this measure is contingent upon statistical significance being demonstrated for the first three outcome measures at the predefined alpha level (0.025).
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset | 145 Participants |
| Comparator | Responder Status Based on Independent Photographic Reviewers Assessment at Week 24 - Per Protocol Dataset | 146 Participants |
p-value: 0.00995% CI: [-8.42, 7.52]McNemar
Secondary
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set
The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the fifth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first four outcome measures demonstrate statistical significance at the predefined alpha level (0.025).
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment; if subjects had received only one treatment (only Princess® FILLER Lidocaine or only Juvéderm® Ultra XC) during initial treatment they would have been excluded from the analysis set. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set | 225 Participants |
| Comparator | Responder Status Based on Treating Investigator Live Assessment at Week 24 - Full Analysis Set | 226 Participants |
p-value: <0.000195% CI: [-3.85, 3.11]McNemar
Secondary
Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set
The percentage of responders based on the treating investigator live assessment at Week 24 after initial treatment and compared to Juvederm® Ultra XC. Responder is defined as having at least one grade improvement over Baseline, on the 5-point Nasolabial Folds-Severity Rating Scale (NLF-SRS). NLF-SRS scores are ranked as 0 (None/minimal), 1 (Mild), 2 (Moderate), 3 (Severe) and 4 (Extreme). Hierarchical Testing Procedure: This is the sixth outcome measure to be analyzed as part of the hierarchical testing sequence. Statistical significance will be assessed only if the first five outcome measures demonstrate statistical significance at the predefined alpha level (0.025).
Time frame: Week 24
Population: The population used consists of all randomized subjects who received Princess® FILLER Lidocaine AND the control Juvéderm® Ultra XC at the same visit as initial treatment and who had no major protocol deviations. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Princess Filler Lidocaine | Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set | 194 Participants |
| Comparator | Responder Status Based on Treating Investigator Live Assessment at Week 24 - Per Protocol Set | 195 Participants |
p-value: <0.000195% CI: [-4.05, 3.16]McNemar