Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds

Study Overview
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Brief Summary
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The aim of this clinical trial is to evaluate the efficacy and safety of Princess® VOLUME for the correction of nasolabial folds.

Official Title
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Open-label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess® VOLUME in Nasolabial Folds

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: Princess® VOLUME


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Male or female subjects between 30 years and 65 years Wrinkle score of at least 2 according to the Modified Fitzpatrick Wrinkle Scale (MFWS) Major Exclusion Criteria: For females: pregnancy, lactating, planned pregnancy or unwilling to use contraceptives History of allergic reaction to hyaluronic acid products Facial surgery or implantation of dermal fillers in the nasolabial region within the last 24 months Skin of the nasolabial region affected by cosmetic treatments (e.g. laser therapy within the last 12 months, chemical peeling within the last 3 months, dermabrasion within the last 12 months, botulinum toxin within the last 12 months ) Connective tissue diseases Diabetes mellitus or uncontrolled systemic diseases Known human immune deficiency virus-positive individuals Presence of silicone implant or another non-absorbable substance (permanent fillers) in the area of product application Cutaneous lesions in the evaluated area Tendency to keloid formation and/or hypertrophic scars Autoimmune disease History of allergies against cosmetic filling products and re-current herpes simplex History of immune system degradation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Princess® VOLUME<br>Injection of Princess® VOLUME into the deep dermis or subcutis of both nasolabial folds. A touch-up treatment may be performed at Day 14 if correction is not complete after the first injection. The injected volumes will be estimated by the investigator and depend on the depth of the nasolabial folds | Device: Princess® VOLUME<br> <br> * Other names: highly cross-linked, viscoelastic hyaluronic acid injectable gel implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Day 180 |  | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Fitzpatrick Wrinkle Scale (MFWS) from Day 0 to Days 30, 90, and 270 |  | Days 30, 90, and 270 | 
| Improvement of at least 0.5 on the Modified Fitzpatrick Wrinkle Scale (MFWS) | Percentage of subjects with an improvement of at least 0.5 on the MFWS at Days 30, 90, 180 and Day 270 | Days 30, 90, 180 and Day 270 | 
| Subject satisfaction | Subject satisfaction at Days 30, 90, 180, and 270 | Days 30, 90, 180, and 270 | 
| Global Aesthetic Improvement | Global Aesthetic Improvement Scale (GAIS) at Days 30, 90, 180, and 270 | Days 30, 90, 180, and 270 | 
| Adverse events |  | Days 0, 14, 30, 90, 180, 270 |