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Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions

NCT02437903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-15

Study results available
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Summary

This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.

Conditions

  • Aging

Interventions

DEVICE

JUVÉDERM VOLUMA™ XC

Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.

Sponsors & Collaborators

  • Baumann Cosmetic and Research Institute

    lead OTHER

Principal Investigators

  • Leslie S Baumann, MD,CPI · Baumann Cosmetic and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-08-07
Primary Completion
2017-04-05
Completion
2017-04-05

Countries

  • United States

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 NCT02437903 on ClinicalTrials.gov