Post Market Study Evaluating Princess Filler 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® FILLER 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® FILLER Lidocaine for the Correction of Nasolabial Folds

Conditions
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Correction of Nasolabial Folds

Intervention / Treatment
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* Device: Princess FILLER 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 NLF-SRS as assessed by the investigator 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: Subjects meeting any of the following criteria should not be enrolled: Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only) History of mental disorders or emotional instability History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermoabrasion, or botulinum toxin application in the nasolabial region within previous twelvemonths, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region Cutaneous lesions in the treatment area Known human immune deficiency virus-positive individuals History of allergies against aesthetic filling products and recurrent herpes simplex Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy Diabetes mellitus or uncontrolled systemic diseases Use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study Previous enrolment in this clinical investigation 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)

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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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Princess® FILLER Lidocaine<br>Princess FILLER Lidocaine injections up to 10 ml given to the patients at baseline time point | Device: Princess FILLER Lidocaine<br>* Princess FILLER Lidocaine injection up to 10 ml given to the patients at baseline time point. After 2 week a touch up is given in case to be consider necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average change versus baseline in the NLF-SRS grade of nasolabial folds at Week 24 as evaluated by the investigator |  | baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasolabial fold severity (NLF-SRS) Weeks 4 and 36 | The average change versus Baseline in the NLF-SRS grade at Week 4 and Week 36 after initial treatment as evaluated by the investigator | 1 and 9 months post injection |