A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-08-02

Brief Summary

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The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.

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Detailed Description

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Conditions

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Age-related Volume Deficit in the Mid-face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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JUVÉDERM VOLUMA® XC Injectable Gel with Cannula

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.

Group Type EXPERIMENTAL

JUVÉDERM VOLUMA® XC injectable gel with cannula

Intervention Type DEVICE

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.

JUVÉDERM VOLUMA® XC Injectable Gel with Needle

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

Group Type OTHER

JUVÉDERM VOLUMA® XC injectable gel with needle

Intervention Type DEVICE

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

Interventions

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JUVÉDERM VOLUMA® XC injectable gel with cannula

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.

Intervention Type DEVICE

JUVÉDERM VOLUMA® XC injectable gel with needle

Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

Exclusion Criteria

* Has any facial procedures or trauma that may interfere with the study procedures and results;
* Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
* Has active autoimmune disease;
* Has current cutaneous or mucosal inflammatory or infectious processes.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No