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Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

NCT00978042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2015-11-03

Study results available
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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.

Conditions

  • Mid-facial Volume Deficit Related to Aging

Interventions

DEVICE

Juvéderm® VOLUMA XC

Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-11-30
Completion
2014-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978042 on ClinicalTrials.gov