Temple Hollowing
Conditions
Brief summary
The objectives of this study are to evaluate the safety and effectiveness of Juvederm® Voluma® XC injectable gel in adult participants seeking correction of temple hollowing
Interventions
DEVICEJUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC injectable gel
OTHERNo-treatment control
Participants received no treatment for 3 months during the Control Period.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants in general good health * Participants seeking improvement of temple hollowing
Exclusion criteria
* Temple hollowing due to trauma, congenital malformations, or lipodystrophy * Temporomandibular joint dysfunction or any other jaw issues * Recurrent temporal headaches such as temporal tendinitis migraine * Active autoimmune disease * History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein * Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy) * Fat injection or permanent facial implants anywhere in the face * Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment * Temporary dermal filler injections above the subnasale within 24 months before enrollment * Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment * Botulinum toxin treatment above the subnasale within 6 months before enrollment * Females who are pregnant, nursing, or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 | Baseline, Month 3 (Control Period) | The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. |
| Number of Participants With Adverse Events | From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 | Month 3 (Control Period) | The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. |
| Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 | Month 3 (Control Period) | Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. |
| Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 | Baseline, Month 3 (Control Period) | The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement. |
| Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire | Baseline, Month 3 (Control Period) | The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement. |
Countries
Puerto Rico, United States
Participant flow
Pre-assignment details
Of 205 participants screened, 171 were randomized, with 113 in the treatment group and 58 in the control group. One participant was randomized to the treatment group but not treated.
Participants by arm
| Arm | Count |
|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period. | 58 |
| JUVÉDERM® VOLUMA® XC Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period. | 113 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Control Period | Lost to Follow-up | 0 | 4 |
| Control Period | Protocol deviation | 0 | 1 |
| Control Period | Withdrawal by Subject | 2 | 2 |
| Maintenance Treatment Period | Lost to Follow-up | 0 | 3 |
| Maintenance Treatment Period | Withdrawal by Subject | 0 | 2 |
| Post-Control Period | Lost to Follow-up | 4 | 9 |
| Post-Control Period | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | JUVÉDERM® VOLUMA® XC | Total | No Treatment Then JUVÉDERM® VOLUMA® XC |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 9.97 | 54.7 years STANDARD_DEVIATION 9.89 | 54.4 years STANDARD_DEVIATION 9.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 41 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 130 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 18 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 94 Participants | 142 Participants | 48 Participants |
| Sex: Female, Male Female | 96 Participants | 143 Participants | 47 Participants |
| Sex: Female, Male Male | 17 Participants | 28 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 112 | 0 / 53 | 0 / 40 |
| other Total, other adverse events | 0 / 59 | 19 / 112 | 16 / 53 | 5 / 40 |
| serious Total, serious adverse events | 2 / 59 | 5 / 112 | 2 / 53 | 4 / 40 |
Outcome results
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.
Time frame: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment
Population: Safety population: all participants who were randomized and received study intervention (JUVÉDERM® VOLUMA® XC or no-treatment control), analyzed by treatment received
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC | Number of Participants With Adverse Events | Any TEAE | 3 Participants |
| No Treatment Then JUVÉDERM® VOLUMA® XC | Number of Participants With Adverse Events | TESAE | 2 Participants |
| JUVÉDERM® VOLUMA® XC | Number of Participants With Adverse Events | Any TEAE | 38 Participants |
| JUVÉDERM® VOLUMA® XC | Number of Participants With Adverse Events | TESAE | 5 Participants |
| JUVÉDERM® VOLUMA® XC (Post-Control Period) | Number of Participants With Adverse Events | TESAE | 2 Participants |
| JUVÉDERM® VOLUMA® XC (Post-Control Period) | Number of Participants With Adverse Events | Any TEAE | 24 Participants |
| JUVÉDERM® VOLUMA® XC (Maintenance Period) | Number of Participants With Adverse Events | TESAE | 4 Participants |
| JUVÉDERM® VOLUMA® XC (Maintenance Period) | Number of Participants With Adverse Events | Any TEAE | 13 Participants |
Primary
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3
The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Time frame: Baseline, Month 3 (Control Period)
Population: Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Multiple imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC | Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 | 13.5 percentage of participants |
| JUVÉDERM® VOLUMA® XC | Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 | 80.4 percentage of participants |
Comparison: JUVÉDERM® VOLUMA® XC Treatment vs No-treatment controlp-value: <0.000195% CI: [54.9, 78.8]Multiple imputation regression
Secondary
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3
The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 3 (Control Period)
Population: Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Overall number of participants analyzed were the participants with analysis values at both Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC | Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 | -6.6 units on a scale | Standard Deviation 8.9 |
| JUVÉDERM® VOLUMA® XC | Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 | 24.2 units on a scale | Standard Deviation 22.32 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire
The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 3 (Control Period)
Population: Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Overall number of participants analyzed were the participants with analysis values at both Baseline and Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC | Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire | -4.2 units on a scale | Standard Deviation 14.77 |
| JUVÉDERM® VOLUMA® XC | Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire | 42.7 units on a scale | Standard Deviation 26.65 |
p-value: <0.0001t-test, 2 sided
Secondary
Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3
The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time frame: Month 3 (Control Period)
Population: Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Participants with analysis values at Month 3 are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC | Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 | 10.7 percentage of participants |
| JUVÉDERM® VOLUMA® XC | Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 | 83.8 percentage of participants |
Secondary
Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3
Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time frame: Month 3 (Control Period)
Population: Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Participants with analysis values at Month 3 are presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Treatment Then JUVÉDERM® VOLUMA® XC | Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 | 2.0 percentage of participants |
| JUVÉDERM® VOLUMA® XC | Percentage of Participants With a Score of Improved or Much Improved on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 | 92.9 percentage of participants |