18 and older, any sex, with Temple Hollowing. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse EventsPrimary· 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/incapacit
Any TEAE
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
23
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
59
TESAE
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
1
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
2
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)Primary· 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.
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
0
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
92
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6Secondary· 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.
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
0.1
± 13.97
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
50.7
± 26.06
Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6Secondary· 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.
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
-4.1
± 13.32
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
36.2
± 26.89
Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)Secondary· 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.
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
0
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
94
Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)Secondary· 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.
Group
Value
95% CI
Control No-Treatment (Months 1 to 6) to JUVÉDERM® VOLUMA® With Lidocaine Treatment (Months 7 to 12)
0
JUVÉDERM® VOLUMA® With Lidocaine (Treatment Months 1 - 12)
93
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 6.4, 12.8 and 6.9 months for No Treatment (Control Period), JUVÉDERM® VOLUMA® with Lidocaine (Treatment Period), and JUVÉDERM® VOLUMA® with Lidocaine (Post-Control Treatment Period), respectively..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Control - No Treatment (Months 1 - 6)
Serious: 1/56 (2%)
Deaths: 0/56
JUVÉDERM® VOLUMA® With Lidocaine (Months 1 - 12)
Serious: 3/112 (3%)
Deaths: 0/112
JUVÉDERM® VOLUMA® With Lidocaine - Post Control (Months 7 - 12)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03430986 — Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the N
· NA
· completed
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 12 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04891419.