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

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

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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