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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Other | Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUMA™ XC | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Satisfaction With Temple Appearance | Subject's Satisfaction with Temple Appearance | Baseline, month 1, month 3, month 6, month 9, and Month 12 |
| Subject Self-Perception of Age | Subjects perception of age when the subject looks at his/her right and left temples |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie S Baumann, MD,CPI | Baumann Cosmetic and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | JUVÉDERM VOLUMA™ XC | Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. 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, and month 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | JUVÉDERM VOLUMA™ XC | Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. 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, and month 6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects with data for for this outcome measure | Posted | Count of Participants | Participants | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
|
Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JUVÉDERM VOLUMA™ XC | Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. 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, and month 6. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexpected Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject experienced unexpected swelling 28 days post injection. Device was removed immediately. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Baumann, MD | Baumann Cosmetic and Research Institute | (305) 531-5788 | studies@derm.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2015 | Jan 19, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2015 | Jan 19, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019066 | Facies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Open Label
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| Baseline, month 1, month 3, month 6, month 9, and Month 12 |
| Number of Participants With Specific Site Treatment Responses | Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections | Day 14 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Secondary | 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. | All subjects with data for this outcome measure | Posted | Count of Participants | Participants | Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12 |
|
|
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| Other Pre-specified | Subject's Satisfaction With Temple Appearance | Subject's Satisfaction with Temple Appearance | All subjects with data for this outcome measure | Posted | Count of Participants | Participants | Baseline, month 1, month 3, month 6, month 9, and Month 12 |
|
|
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| Other Pre-specified | Subject Self-Perception of Age | Subjects perception of age when the subject looks at his/her right and left temples | All subjects with data for this outcome measure | Posted | Count of Participants | Participants | Baseline, month 1, month 3, month 6, month 9, and Month 12 |
|
|
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| Other Pre-specified | Number of Participants With Specific Site Treatment Responses | Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections | Total number of subjects that reported symptom | Posted | Count of Participants | Participants | Day 14 |
|
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
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| Flat |
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| Convexity |
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| Flat |
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| Convexity |
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| Flat |
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| Convexity |
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| Flat |
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| Convexity |
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| Flat |
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| Convexity |
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| Somewhat Satisfied |
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| Neither |
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| Somewhat Dissatisfied |
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| Moderately Dissatisfied |
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| Very Dissatisfied |
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| Investigator's Satisfaction at Month 1 |
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| Investigator's Satisfaction at Month 3 |
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| Investigator's Satisfaction at Month 6 |
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| Investigator's Satisfaction at Month 9 |
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| Investigator's Satisfaction at Month 12 |
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| Somewhat Satisfied |
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| Neither |
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| Somewhat Dissatisfied |
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| Moderately Dissatisfied |
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| Very Dissatisfied |
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| Subject's Satisfaction at Month 1 |
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| Subject's Satisfaction at Month 3 |
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| Subject's Satisfaction at Month 6 |
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| Subject's Satisfaction at Month 9 |
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| Subject's Satisfaction at Month 12 |
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| 6-10 Years Younger |
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| 11-15 Years Younger |
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| 16+ Years Younger |
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| Returned to Baseline |
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| Subjects perception of age at Month 1 |
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| Subjects perception of age at Month 3 |
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| Subjects perception of age at Month 6 |
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| Subjects perception of age at Month 9 |
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| Subjects perception of age Month 12 |
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| Severe |
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| Swelling |
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| Lumps/Bumps |
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| Bruising |
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| Redness |
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| Itching |
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| Headache |
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| Jaw Pain/Tension |
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