Adults 40 to 65, female only, with Cheek Line Depressions. 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.
Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)Primary· Baseline (Day 1) to Day 45
Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.
Improved
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
98.1
Not Improved
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
1.9
Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®Secondary· Baseline (Day 1) to Day 45
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicate
Baseline (Day 1)
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
96.6
± 53.6
Change from Baseline at Day 45
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
-24.8
± 31.9
Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®Secondary· Baseline (Day 1) to Day 45
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates tha
Baseline (Day 1)
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
203.1
± 72.3
Change from Baseline at Day 45
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
-35.3
± 43.6
Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®Secondary· Baseline (Day 1) to Day 45
The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates tha
Baseline (Day 1)
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
511.8
± 217.8
Change from Baseline at Day 45
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
-115.1
± 129.4
Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAISSecondary· Baseline (Day 1) to Day 45
The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.
Responder
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
94.2
Partial Responder
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
1.9
No Responder
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
3.8
Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) QuestionnaireSecondary· Baseline (Day 1) to Day 45
The SPA questionnaire consists of one question: "How do you think your facial appearance looks compared to your age TODAY?" Participants could choose one of three possible answers: "I look my current age," "I look younger," or "I look older." The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.
Baseline (Day) 1: I look my current age
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
53
Baseline (Day) 1: I look younger
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
28
Baseline (Day) 1: I look older
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
19
Day 45: I look my current age
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
38
Day 45: I look younger
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
60
Day 45: I look older
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
2
Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant QuestionnaireSecondary· Day 45
Participants were asked to indicate their level agreement with the following statement: "The treatment of my smile lines gave me a natural look." Responses were scored from 0 to 10, where 0=not at all to 10=very much.
Group
Value
95% CI
Juvéderm® VOLIFT®™ With Lidocaine
7.2
± 2.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 59 Days after the First Injection.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 15 February 2019
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/NCT02980783.