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.
Volume deficit in the temporal area (the side of the forehead) of the face is a common sign
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
JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12
- 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
- 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
- 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
- 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.