Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open-label, Multicenter, Post-market Study Evaluating Princess® VOLUME Lidocaine for the Correction of Nasolabial Folds

Conditions
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Nasolabial Fold, Hypoplastic

Intervention / Treatment
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* Device: Princess® VOLUME Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older 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 Healthy skin in the facial area and free of diseases that could interfere in cutaneous aging evaluation Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of the clinical investigation Written signed and dated informed consent Exclusion Criteria: Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only) History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anesthetic Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region Cutaneous lesions in the treatment area History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy Use of anticoagulant, antiplatelet or thrombolytic medication Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Princess® VOLUME Lidocaine for the correction of nasolabial folds
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Princess® VOLUME Lidocaine<br> | Device: Princess® VOLUME Lidocaine<br>* Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NLF-SRS grade of nasolabial folds | The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator | 24 weeks | 
| NLF-SRS grade of nasolabial folds | The proportion of subjects with the NLF-SRS grade reduced by ≥1 point versus baseline at Week 24 | 24 weeks |