A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

Study Overview
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Brief Summary
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This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.

Official Title
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A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

Conditions
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Nasolabial Fold, Safety

Intervention / Treatment
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* Device: GP0045
* Device: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study Signed and dated informed consent to participate in the study, including photo consent Subjects with intent to undergo correction of both nasolabial folds Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) Participation in any other clinical study with an investigational product within 30 days before treatment

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP0045<br>Treatment with GP0045 | Device: GP0045<br>* Hyaluronic acid gel<br>|
| Active Comparator: Comparator<br>Treatment with active comparator | Device: Comparator<br>* Hyaluronic acid gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale | The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator. | 2 weeks, 3, 9, 12, 15 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, Lidocaine