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Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation

NCT01197495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2019-04-16

Study results available
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Summary

The purpose of this study is to demonstrate the safety and effectiveness of Juvederm(R) Ultra XC Injectable Gel for lip augmentation

Conditions

  • Lip Augmentation

Interventions

DEVICE

hyaluronic acid gel

Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-01
Primary Completion
2014-06-19
Completion
2015-06-15

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 NCT01197495 on ClinicalTrials.gov