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NCT00978042 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
A NA study of Mid-facial Volume Deficit Related to Aging, sponsored by Allergan.
- Completed
- Registry status
- NA
- Development phase
- 345
- Enrollment target
- 2
- Study locations
NCT00978042: Completed NA study of Mid-facial Volume Deficit Related to Aging, sponsored by Allergan.
NCT00978042 is a NA study of Mid-facial Volume Deficit Related to Aging that has completed, run by Allergan. The registered enrollment target is 345 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00978042, a NA study of Mid-facial Volume Deficit Related to Aging, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- NA
- Development phase
- 345 participants
- Enrollment target
- 2
- Study locations
Study Summary
Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.
Primary Outcome
The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment as
Conditions Studied
Interventions
- DEVICE Juvéderm® VOLUMA XC
Study Locations (2)
California
- - Los Angeles
British Columbia
- - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-04 |
| Phase | NA |
What the finished NCT00978042 record still lists
NCT00978042 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Mid-facial Volume Deficit Related to Aging appearing as the primary indexed condition, and to 1 intervention - of which Juvéderm® VOLUMA XC is the first listed.
NCT00978042 reports a single indexed study location in California, British Columbia.
Frequently Asked Questions
What is clinical trial NCT00978042 about?
NCT00978042 is a clinical study titled "Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation". Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.
What is the current status of trial NCT00978042?
This trial is currently completed. It is a NA study. The enrollment target is 345 participants. The study started on 2009-08. Estimated completion is 2014-04.
What conditions does trial NCT00978042 study?
This clinical trial studies the following conditions: Mid-facial Volume Deficit Related to Aging.
What interventions are being tested in trial NCT00978042?
The interventions under investigation include: Juvéderm® VOLUMA XC (DEVICE).
Who is sponsoring clinical trial NCT00978042?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00978042 being conducted?
This trial has 2 study locations across California, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00978042's enrollment target sits among peer trials
345 302nd of 2000 higher than 1,699 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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