Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Tempora… (NCT02437903) | Clinical Trial Compass
CompletedNot Applicable
Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
United States30 participantsStarted 2015-08-07
Plain-language 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.
Who can participate
Age range35 Years – 75 Years
SexALL
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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 …