Temple Hollowing
Conditions
Brief summary
The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM® VOLUMA® with Lidocaine injectable gel in adult Chinese population seeking correction of temple hollowing.
Interventions
JUVÉDERM® VOLUMA® with Lidocaine injectable gel
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be 18 or over, at the time of signing the ICF * Participants seeking improvement of temple hollowing * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol * Written informed consent from the participant has been obtained prior to any study-related procedures * Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable * Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all participant self-assessments)
Exclusion criteria
* Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired * Has experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring * Temporal arteritis or history of temporal arteritis * Temporomandibular joint dysfunction or any other jaw issues * Recurrent temporal headaches such as temporal tendinitis migraine * Active or recurrent inflammation or infection in either eye * Tendency to develop hypertrophic scarring * Active autoimmune disease * History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein * Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal * 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 12 months before enrollment * Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures. * Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment * Botulinum toxin treatment above the subnasale within 6 months before enrollment * Has braces or other orthodontics * Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study * Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel) * Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple * Females who are pregnant, nursing, or planning a pregnancy * Plans a significant weight change (more than 10% of body weight) during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 14 Months | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug. |
| Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS) | Change from Baseline to Month 6 | The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Improved or Much Improved as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | Month 6 | The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. |
| Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6 | Change from Baseline to Month 6 | Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. |
| Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6 | Change from baseline to Month 6 | Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement. |
| Participants Improved or Much Improved as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS) | Month 6 | Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse. |
Countries
China
Participant flow
Pre-assignment details
The 168 participants were enrolled and randomized (2:1 ratio) to a 12-month treatment group or a 6-month no-treatment group. Participants who completed the no-treatment group had the option to move to a post-control 6-month treatment group. A total of 112 participants were randomized to the 12-month treatment (JUVÉDERM® VOLUMA® with Lidocaine) group and 56 participants were initially randomized to the no-treatment control group.
Participants by arm
| Arm | Count |
|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) No treatment is administered during the Control No-Treatment period (Months 1 to 6). Only those participants that opt to go on to the Control Treatment period will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. | 56 |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch-up treatment. | 112 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Total |
|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 8.16 | 37.3 years STANDARD_DEVIATION 9.22 | 36.5 years STANDARD_DEVIATION 8.93 |
| Age, Customized 40 - 65 years | 13 Participants | 35 Participants | 48 Participants |
| Age, Customized < 40 years | 43 Participants | 75 Participants | 118 Participants |
| Age, Customized > 65 years | 0 Participants | 2 Participants | 2 Participants |
| Allergan Temple Hollowing Scale Minimal | 22 Participants | 42 Participants | 64 Participants |
| Allergan Temple Hollowing Scale Moderate | 29 Participants | 62 Participants | 91 Participants |
| Allergan Temple Hollowing Scale Severe | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 56 Participants | 112 Participants | 168 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 53 Participants | 103 Participants | 156 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 112 | 0 / 53 |
| other Total, other adverse events | 18 / 56 | 62 / 112 | 19 / 53 |
| serious Total, serious adverse events | 1 / 56 | 3 / 112 | 2 / 53 |
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 subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
Time frame: Up to 14 Months
Population: Control Period - Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Number of Participants With Adverse Events | Any TEAE | 23 Participants |
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Number of Participants With Adverse Events | TESAE | 1 Participants |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Number of Participants With Adverse Events | Any TEAE | 59 Participants |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Number of Participants With Adverse Events | TESAE | 2 Participants |
Primary
Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS)
The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
Time frame: Change from Baseline to Month 6
Population: Control Period - Observed Primary Endpoint Population~N = Participants with analysis values at both baseline and Month 6 Visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS) | 0 participants |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Participants With at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) Using the Allergan Temple Hollowing Scale (ATHS) | 92 participants |
p-value: <0.000195% CI: [83.7, 95.9]Fisher Exact
Secondary
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6
Participant-assessed satisfaction using the 10-item FACE-Q Satisfaction with Facial Appearance Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Time frame: Change from baseline to Month 6
Population: Control Period - Modified Intent-to-Treat Population~Participants with analysis values at both baseline and the specified analysis visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6 | -4.1 units on a scale | Standard Deviation 13.32 |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6 | 36.2 units on a scale | Standard Deviation 26.89 |
p-value: <0.000195% CI: [37.6, 48]Mixed Models Analysis
Secondary
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6
Participant-assessed satisfaction using the 12-item FACE-Q Satisfaction with Temples Questionnaire was measured on a 4-point scale where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. The responses to the items were converted to a 100-point Rasch transformed score ranging from 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Time frame: Change from Baseline to Month 6
Population: Control Period - Modified Intent-to-Treat Population~N = Participants with analysis values at both baseline and the specified analysis visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6 | 0.1 units on a scale | Standard Deviation 13.97 |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6 | 50.7 units on a scale | Standard Deviation 26.06 |
p-value: <0.000195% CI: [49.2, 59.9]Mixed Models Analysis
Secondary
Participants Improved or Much Improved as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Time frame: Month 6
Population: Control Period - Modified Intent-to-Treat Population~Participants with analysis values at both baseline and the specified visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Participants Improved or Much Improved as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | 0 Participants |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Participants Improved or Much Improved as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS) | 93 Participants |
p-value: <0.000195% CI: [84.9, 96.5]Fisher Exact
Secondary
Participants Improved or Much Improved as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)
Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
Time frame: Month 6
Population: Control Period - Modified Intent-to-Treat Population~Participants with analysis values at both baseline and the specified visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12) | Participants Improved or Much Improved as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS) | 0 Participants |
| JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12) | Participants Improved or Much Improved as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS) | 94 Participants |
p-value: <0.000195% CI: [86.1, 97.2]Fisher Exact