Prospective Evaluation of Facial Cosmetic Procedures

Study Overview
=================
Brief Summary
-----------------
A prospective, trial to quantitatively and qualitatively compare the dermal fillers for the treatment of age related aesthetic changes.

Detailed Description
-----------------
Dermal fillers have been approved for the treatment of age related aesthetic changes, including facial volume loss, and attenuation of the static and dynamic rhytid. Despite widespread use of volumizing fillers there is little data quantifying the subjective benefit of these minimally invasive treatments from the patient perspective. Furthermore, there is little data comparing the subjective benefit with true objective volumetric results. Such data will provide much needed information for patient counselling and treatment optimization for patient perceived outcomes. This study is to determine the patient reported outcomes of three different dermal fillers and establish the volumetric changes over 90 days. Screening will be performed during the patient's office visit. Approximately 100 patients will be enrolled. Patients will participate up to 90 days (Day 1, 14 days, 28 days, and 90 days).

Official Title
-----------------
Prospective Evaluation of Minimally Invasive Facial Cosmetic Procedures Through Measured Volumetric Changes and Patient Reported Outcomes

Conditions
-----------------
Cosmetic Techniques

Intervention / Treatment
-----------------
* Drug: Restylane-L®
* Drug: Restylane-L® Lyft
* Drug: Restylane Silk®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 40 - 65 years of age Exclusion Criteria: Male patients Prior surgical facial rejuvenation procedures Facelift Neck lift Blepharoplasty Facial fat grafting Prior minimally invasive rejuvenation procedure ≤ 12 months Known contraindications to devices or drugs used in this study Facial paralysis Congenital facial asymmetry Pregnant women Patient actively taking blood thinners

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane-L®, Restylane-L® Lyft, and Restylane Silk®<br>Hyaluronic acid | Drug: Restylane-L®<br>* Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.<br>* Other names: Hyaluronic acid gel;Drug: Restylane-L® Lyft<br>* Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).<br>* Other names: Hyaluronic acid gel;Drug: Restylane Silk®<br>* Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.<br>* Other names: Hyaluronic acid gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with validated FACE-Q survey | Patient satisfaction with validated survey FACE-Q | upto 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate patient satisfaction with volumetric measurements | regression analysis of satisfaction scores with changes in volumetric measurements | upto 90 days | 
| Volumetric changes of treatment | 3-dimensional photography to measure volumetric changes in each treatment | upto 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
facial filler, Retylane, aesthetic improvement, volumizing fillers