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

Completed · Not applicable

Conditions studied: Age-related Volume Deficit in the Mid-face

In brief

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.

Key facts

Study ID

NCT03438266

Run by

Allergan

People needed

66

Starts

2018-02-05

Expected to finish

2018-08-02

Last updated by the study team

2019-08-05

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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);

You may not qualify if…

• 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.

Where it is running

• Skin Care and Laser Physicians of Beverly Hills — Los Angeles, California, United States
• Art of Skin MD — Solana Beach, California, United States
• Baumann Cosmetic and Research Institute — Miami, Florida, United States
• Saint Louis University Dermatology — St Louis, Missouri, United States
• Skin Laser & Surgery Specialists of NY/NJ — Hackensack, New Jersey, United States
• Rhoda S. Narins, MD, PC — White Plains, New York, United States
• Aesthetic Solutions, PA — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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