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

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Allergan

Status

Completed

Conditions

Age-related Volume Deficit in the Mid-face

Treatments

Device: JUVÉDERM VOLUMA® XC injectable gel with needle
Device: JUVÉDERM VOLUMA® XC injectable gel with cannula

Study type

Interventional

Funder types

Industry

Identifiers

NCT03438266
1650-801-008

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

JUVÉDERM VOLUMA® XC Injectable Gel with Cannula
Experimental group
Description:
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
Treatment:
Device: JUVÉDERM VOLUMA® XC injectable gel with cannula
JUVÉDERM VOLUMA® XC Injectable Gel with Needle
Other group
Description:
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Treatment:
Device: JUVÉDERM VOLUMA® XC injectable gel with needle

Trial documents
2

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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