Status:
COMPLETED
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Lead Sponsor:
Allergan
Conditions:
Age-related Volume Deficit in the Mid-face
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
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-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03438266
Start Date
February 5 2018
End Date
August 2 2018
Last Update
August 5 2019
Active Locations (7)
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1
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
2
Art of Skin MD
Solana Beach, California, United States, 92075
3
Baumann Cosmetic and Research Institute
Miami, Florida, United States, 33137
4
Saint Louis University Dermatology
St Louis, Missouri, United States, 63122