Effectiveness and Safety of Princess FILLER Lidocaine in Correction of Nasolabial Folds (NLF)

Study Overview
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Brief Summary
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Clinical Investigation to demonstrate the effectiveness and safety of Princess Filler Lidocaine in the correction of moderate to severe nasolabial folds

Detailed Description
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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

Official Title
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A Randomized, Subject- and Evaluating Investigator-blinded, Controlled, Multicenter, Split-face, Comparison Clinical Investigation to Evaluate Effectiveness and Safety of Princess FILLER Lidocaine in the Correction of Nasolabial Folds

Conditions
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Dermatological Non-Disease

Intervention / Treatment
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* Device: Princess Filler Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over or equal 22 years at screening approximately symmetrical moderate to severe nasolabial folds negative urine pregnancy test healthy skin willing to abstain from aesthetic or surgical procedures in the treatment area written informed consent Exclusion Criteria: pregnant and/or lactating history of allergies or hypersensitivity to e.g. hyaluronic acid preparations tendency to keloid formation HIV positive presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions herpes simplex in treatment area autoimmune or connective tissue disease, immunomodulating therapy uncontrolled diabetes or systemic diseases Facial plastic surgery, tissue augmentation implantation of facial dermal fillers within 12 months Skin of nasolabial region affected by aesthetic treatments Facial lipolysis Bariatric surgery within 12 months History of bleeding disorder Planned dental/oral surgery Any medical condition prohibiting the inclusion according to the investigator Previous enrollment Current participation in another clinical investigation within 30 days prior to enrollment Dependency of the subject to the investigation site

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pivotal study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment of device 1 on left side<br>Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to left NLF, Comparator is assigned to right NLF | Device: Princess Filler Lidocaine<br>* correction of nasolabial folds<br>|
| Other: Treatment of device 1 on right side<br>Treatment of nasolabial folds (NLF) with both Investigational Device and Comparator; Princess Filler Lidocaine is assigned to right NLF, Comparator is assigned to left NLF | Device: Princess Filler Lidocaine<br>* correction of nasolabial folds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| independent evaluating investigator live assessment | percentage of responders based on the independent evaluating investigators live assessment | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| independent photographic reviewers assessment | percentage of responders based on the independent photographic reviewers assessment | Week 24 | 
| treating investigator live assessment | percentage of responders based on the treating investigators live assessment | Week 24 | 
| Improvement over Baseline - investigator assessment | percentage of subjects with improvement based on the independent evaluating investigators assessment | Week 24 | 
| Improvement over Baseline - subject assessment | percentage of subjects with improvement based on the subjects assessment | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasolabial folds, correction