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

Description

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

Study Start Date

February, 05 2018

Estimated Completion Date

September 2018

Interventions

  • Device: JUVÉDERM VOLUMA® XC injectable gel cannula side
  • Device: JUVÉDERM VOLUMA® XC injectable gel needle side

Study ID

Allergan -- 1650-801-008

Status

Recruiting

Trial ID

NCT03438266

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

75

Sponsor

Allergan

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 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 anaesthetics), 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

Gender

All

Ages

35 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
Rhoda S Narins MD PC - White Plains, New York 28.7 miles None None None
Skin Laser Surgery Specialists of NYNJ - Hackensack, New Jersey 47.6 miles None None None
Aesthetic Solutions PA - Chapel Hill, North Carolina 481.5 miles None None None
Saint Louis University Dermatology - Saint Louis, Missouri 928.7 miles None None None
Baumann Cosmetic and Research Institute - Miami, Florida 1,138.7 miles None None None
Art of Skin MD - Solana Beach, California 2,469.3 miles None None None
Skin Care and Laser Physicians of Beverly HillsSkin Care and Laser Physicians of Beverly Hills - Los Angeles, California 2,495.1 miles None None None

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