Restylane® for the Treatment of Tear Trough Deformity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effectiveness and tolerability of Restylane® for correction of tear trough deformity, using various injection techniques.

Official Title
-----------------
A Clinical Evaluation of the Efficacy and Safety of Hyaluronic Acid (Restylane®) for the Treatment of Tear Trough Deformity

Conditions
-----------------
Tear Trough Eyelid Deformity

Intervention / Treatment
-----------------
* Device: Restylane®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female; Age of 18 years or greater; Indication for treatment of bilateral tear trough deformity; Symmetry of tear trough deformity at baseline; Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure. Exclusion Criteria: Prior (<1 year) or planning to undergo any surgery in the corporal area of interest for study; Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments; Diabetes mellitus type 1 or type 2; Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments; Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors; Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; Pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential); Restylane® should not be used in any person who has hypersensitivity to any of the components of the product; Active skin inflammation or infection in or near the treatment area; Possessing any of the contraindications for use of Restylane®; Septal fat herniation; Severe elastosis (e.g., dermatochalasis); Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment. Use of tear trough injections in the last 12 months. Use of anterior midface injections in the last 12 months.

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients in this current trial will initially be randomized to either needle or cannula injections, or no treatment (control; ratio 3:3:1, respectively). Subjects will proceed from randomization in parallel assignment. Subjects initially randomized to the control group at Baseline will be randomized to either needle or cannula treatment at Visit 3, Month 1 (crossover). Subjects in the crossover group will then be seen at weeks 2 and 4 post last treatment, as per Schedule 1.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment at baseline<br> | Device: Restylane®<br>* Hyaluronic acid<br>|
| Active Comparator: Treatment at Month 1<br> | Device: Restylane®<br>* Hyaluronic acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAIS | Improvement via the blinded evaluator-assessed Global Aesthetic Improvement Scale (GAIS), at the one-month follow up visit. Improvement will be considered as any point-increase above 0 (no change). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Safety measurements will be evaluated by the incidence, seriousness, severity and relationship with the medical device to adverse events reported, at all visits. | Baseline to end of study (up to week 10) |