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NCT03418545 · ClinicalTrials.gov registry record · Phase 3
A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 163
- Enrollment target
NCT03418545: Completed Phase 3 study, sponsored by Allergan.
NCT03418545 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 163 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03418545, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 163 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM® VOLBELLA™ XC in adult participants seeking correction of hollowing of the tear troughs.
Primary Outcome
The evaluating investigator assessed hollowing in both infraorbital areas using the 5-point photonumeric AIHS where: 0=none (no visible hollowing or volume loss medially or laterally), 1=minimal (presence of hollowing with some volume loss medial to the mid-pupillary line; smooth lateral lid-cheek transition), 2=moderate (defined hollowing extending laterally beyond the mid-pupillary line with moderate volume loss; smooth lateral lid-cheek transition with mild volume loss), 3=severe (defined hol
Interventions
- DEVICE JUVÉDERM VOLBELLA® XC injectable gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2018-01-26 |
| Est. Completion | 2019-08-22 |
| Phase | Phase 3 |
What the finished NCT03418545 record still lists
NCT03418545 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which JUVÉDERM VOLBELLA® XC injectable gel is the first listed.
NCT03418545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03418545 about?
NCT03418545 is a clinical study titled "A Safety and Effectiveness of VOLBELLA XC Hyaluronic Acid (HA) Injectable Gel to Correct Infraorbital Hollowing". The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM® VOLBELLA™ XC in adult participants seeking correction of hollowing of the tear troughs.
What is the current status of trial NCT03418545?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 163 participants. The study started on 2018-01-26. Estimated completion is 2019-08-22.
What interventions are being tested in trial NCT03418545?
The interventions under investigation include: JUVÉDERM VOLBELLA® XC injectable gel (DEVICE).
Who is sponsoring clinical trial NCT03418545?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03418545's enrollment target sits among peer trials
163 1471st of 2000 higher than 527 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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