Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

Study Overview
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Brief Summary
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This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

Detailed Description
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Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Official Title
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A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds

Conditions
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Facial Wrinkles

Intervention / Treatment
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* Device: CosmetaLife
* Device: Restylane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older Patients with moderate nasolabial folds (3-4 WSRS scale) Patients willing to provide written informed consent for their participation in the study Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit Exclusion Criteria: Patients with any aesthetic facial therapy within 6 months prior to Patients with an any reaction to the skin test Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy Patients with an active infection of any kind, skin disease, connective tissue disorder Patients who are pregnant or lactating Patients enrolled in another investigational clinical trial

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CosmetaLife<br>Test Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator. | Device: CosmetaLife<br>* Dermal filler<br>|
| Active Comparator: Restylane<br>Control Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator. | Device: Restylane<br>* Dermal filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkle Severity Rating Scale | To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded. | baseline and 6 months | 
| Adverse Event Reporting |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months |  | 3, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasolabial folds, Dermal filler, Injectable dermal filler, Soft tissue augmentation