Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions

Study Overview
=================
Brief Summary
-----------------
This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.

Detailed Description
-----------------
Volume deficit in the temporal area (the side of the forehead) of the face is a common sign of aging. JUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area. JUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation, produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal injection. JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12 months.

Official Title
-----------------
Open Label, Single-center Study, Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Device: JUVÉDERM VOLUMA™ XC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to read and sign the informed consent and other study documents. Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale. Written informed consent has been obtained prior to any study-related procedures. Written Authorization for Use and Release of Health and Research Study Information has been signed. Ability to follow study instructions and complete study assessment tools including the subject diary Female patients of childbearing potential must have a negative urine pregnancy test result and not be lactating. Likely to complete all required visits with no plans to move from Miami in the next 12 months Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, subcutaneous fat injections, any other permanent or semi-permanent facial fillers. Exclusion Criteria: Any uncontrolled systemic disease History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease. Have a history of severe allergic/anaphylactic reactions or multiple allergies. Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma. Females planning to become pregnant, are pregnant, or are breast-feeding. History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit Have severe thin skin, in the treatment area as determined by the PI. Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. Have undergone facial plastic surgery (with the exception of rhinoplasty or a brow lift), tissue grafting, or tissue augmentation with silicone, fat, or other permanent or semi-permanent dermal fillers or be planning to undergo any of these procedures affecting the treatment area, at any time during the study. Unwilling to undergo injections in the temple area. Have a history of migraines or frequent headaches, as determined by the PI. Have blindness or partial vision loss in either eye. Have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study. Patient who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study. Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g.,warfarin), anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed. Have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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 |
| --- | --- |
| Other: JUVÉDERM VOLUMA™ XC<br>Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. | Device: JUVÉDERM VOLUMA™ XC<br>* Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.<br>* Other names: Injectable Dermal Filler;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frontal Temporal Fossa Rating Scale | Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score. | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Satisfaction With the Appearance of the Temporal Regions | Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side. | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voluma temporal, facial, volume loss