Phase 4
Completed N=53
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
Cheek Line Depressions
Source: ClinicalTrials.gov NCT02980783 ↗
Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: 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) — 98.1; 1.9 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
98.1; 1.9 | — |
| SECONDARY Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® |
96.6; -24.8 | — |
| SECONDARY Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® |
203.1; -35.3 | — |
| SECONDARY Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP® |
511.8; -115.1 | — |
| SECONDARY Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile |
— | — |
| SECONDARY Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS |
94.2; 1.9; 3.8 | — |
| SECONDARY Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire |
53; 28; 19; 38; 60; 2 | — |
| SECONDARY Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire |
7.2 | — |
Eligibility Criteria
Inclusion Criteria
- Presence of dynamic radial cheek lines
- Agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study
Exclusion Criteria
- Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study
- Undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry
- Received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study
Data sourced from ClinicalTrials.gov (NCT02980783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.