Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3

Study Overview
=================
Brief Summary
-----------------
This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds

Official Title
-----------------
Monocentric, Randomized, Subject and Rater Blinded Clinical Investigation to Prove the Non-inferiority of Belotero® Basic Versus Juvéderm® Ultra 3 Containing Lidocaine - After Single Injection for Correction of Nasolabial Folds (NLF)

Conditions
-----------------
Physiological Stress, Disorder of Aging, Skin Diseases, Wrinkles, Nasolabial Folds

Intervention / Treatment
-----------------
* Device: Hyaluronic Acid Filler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with bilateral, symmetrical NLF and wish for correction. Documented severity of NLF score 2 or 3 at screening on the Merz Wrinkle Severity Rating Scale II Exclusion Criteria: Any severe or uncontrolled systemic disease (e.g. cardiac, renal, pulmonary, hepatic, or gastrointestinal). Subject suffering from diabetes mellitus, autoimmune and rheumatic diseases, clinically relevant coagulation disorders, recurrent angina, or severe psychic, neurological or mental disease History of malignancy within the last 5 years before the study Infection, inflammations or active dermatological disease in the face

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid Filler - Medical Device<br> | Device: Hyaluronic Acid Filler<br>* The dosage is individualized depending on the depth of the NLF. The goal is to achieve optimal correction of both NLF with single implantations of Belotero® Basic and Juvéderm® Ultra 3 respectively. Each subject will be injected with Belotero® Basic and Lidocaine containing Juvéderm® Ultra 3 according to a split-face design. The allocation of fillers to the side of the face will be randomized. The randomization method is block-wise with a ratio 1:1 to the groups Belotero® Basic left and Juvéderm® Ultra 3 right, Belotero® Basic right and Juvéderm® Ultra 3 left.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects reporting an equal or better outcome for the side of face treated with Belotero® Basic compared to the side of face treated with Juvéderm® Ultra 3 at V4 on the validated Wrinkle Severity Rating Scale II |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation |  | Week 0 | 
| Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation |  | 2 Weeks | 
| Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation |  | 4 Weeks | 
| Overall absolute score change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater |  | Week 0 | 
| Overall absolute score change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater |  | 2 Weeks | 
| Overall absolute score change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater |  | 4 Weeks | 
| Proportion of overall responders i.e. at least 1 point improvement in the validated Wrinkle Severity Rating Scale II(WSRS II) at V4, based on the intra-individual change in WSRS II compared to baseline before implantation, V2 pre implantation |  | 4 Weeks | 
| Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4 |  | 4 Weeks | 
| Overall GAIS by photo rating of an individual rater V2 post implantation and V4 |  | 4 Weeks | 
| Subject Satisfaction Questionnaire results at V2 pre and post implantation |  | Week 0 | 
| Subject Satisfaction Questionnaire results at V3 |  | 2 Weeks | 
| Subject Satisfaction Questionnaire results at V4 |  | 4 Weeks | 
| Global assessment of subject comfort at V2 post implantation by the investigator and the subject. |  | Week 0 | 
| Global assessment of subject comfort at V3 by the investigator and the subject |  | 2 Weeks | 
| Global assessment of subject comfort at V4 by the investigator and the subject |  | 4 Weeks | 
| Proportion of subjects feeling the implant at V2 post implantation |  | Week 0 | 
| Proportion of subjects feeling the implant at V3. |  | 2 Weeks | 
| Proportion of subjects feeling the implant at V4 |  | 4 Weeks | 
| Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4 |  | 4 Weeks |