Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02437903|
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : May 16, 2017
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aging||Device: JUVÉDERM VOLUMA™ XC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Open Label, Single-center Study, Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions|
|Actual Study Start Date :||August 7, 2015|
|Actual Primary Completion Date :||April 5, 2017|
|Actual Study Completion Date :||April 5, 2017|
JUVÉDERM VOLUMA™ XC
Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.
Device: JUVÉDERM VOLUMA™ XC
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.
Other Name: Injectable Dermal Filler
- Frontal Temporal Fossa Rating Scale [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 ]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.
- Investigator's Satisfaction With the Appearance of the Temporal Regions [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 ]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.
- Subject's Satisfaction With Temple Appearance [ Time Frame: Baseline, month 1, month 3, month 6, month 9, and Month 12 ]Subject's Satisfaction with Temple Appearance
- Subject Self-Perception of Age [ Time Frame: Baseline, month 1, month 3, month 6, month 9, and Month 12 ]Subjects perception of age when the subject looks at his/her right and left temples
- Number of Participants With Specific Site Treatment Responses [ Time Frame: Day 14 ]Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437903
|United States, Florida|
|Baumann Cosmetic and Research Institute|
|Miami, Florida, United States, 33137|
|Principal Investigator:||Leslie S Baumann, MD,CPI||Baumann Cosmetic and Research Institute|