Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00978042
First received: September 15, 2009
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.


Condition Intervention
Mid-facial Volume Deficit Related to Aging
Device: Juvéderm® VOLUMA XC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary effectiveness variable was responder rate for the treatment group. To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the subject's overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. To meet the primary effectiveness endpoints, responder rate for the treatment group had to be significantly greater than 70%, as determined by an exact binomial test at 0.025 significance level, and significantly greater than the responder rate for the control group, as determined by a 2-sided Fisher's exact test at the 0.025 significance level.


Secondary Outcome Measures:
  • Duration of Treatment Effect [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of subjects in the treatment group that maintained at least a 1-point improvement in the overal mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators' assessments (with 95% Greenwood's Confidence Interval).


Enrollment: 345
Study Start Date: August 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VOLUMA XC
Subjects injected with VOLUMA XC at start of study
Device: Juvéderm® VOLUMA XC
Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion.
VOLUMA XC No Treatment
Subjects delayed treatment with VOLUMA XC for 6 months
Device: Juvéderm® VOLUMA XC
Treating Investigator determines the appropriate volume of VOLUMA XC to be injected up to a maximum total of 12 mL for initial and touch-up treatment. One repeat treatment with up to 12 mL may be performed at the Subject's option after study completion.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, 35-65 years of age
  • Zygomaticomalar region, anteromedial cheek, submalar region, and/or overall mid-facial volume deficit assessed by the Treating Investigator as grade 3, 4, or 5 on the photometric Mid-Face Volume Deficit Scale (MFVDS)
  • Desire cheek augmentation to correct age-related volume deficit in the mid-face
  • Accept the obligation not to receive any other facial procedures or treatments affecting facial volume deficit at any time during the study

Exclusion Criteria:

  • Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection [Study device injections may be delayed as necessary to accommodate this 10-day wash-out period.]
  • Have undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study
  • Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study
  • Have begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study.
  • Have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads
  • Have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy, partial lipodystrophy, inherited disease, or HIV-related disease
  • Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study
  • Have noticeable acne scarring, an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978042

Locations
United States, California
Los Angeles, California, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Allergan Medical
  More Information

Publications:
Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00978042     History of Changes
Other Study ID Numbers: VOLUMA-002
Study First Received: September 15, 2009
Results First Received: November 22, 2013
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 20, 2014