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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT00978042
First received: September 15, 2009
Last updated: October 6, 2014
Last verified: June 2014

September 15, 2009
October 6, 2014
August 2009
November 2012   (final data collection date for primary outcome measure)
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.
Score on validated 6-point Mid-Face Volume Deficit Scale (MFVDS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00978042 on ClinicalTrials.gov Archive Site
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).
Duration of treatment (survival analysis of primary outcome measure returning to pre-treatment level) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Mid-facial Volume Deficit Related to Aging
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.
  • Experimental: VOLUMA XC
    Subjects injected with VOLUMA XC at start of study
    Intervention: Device: Juvéderm® VOLUMA XC
  • VOLUMA XC No Treatment
    Subjects delayed treatment with VOLUMA XC for 6 months
    Intervention: Device: Juvéderm® VOLUMA XC
Jones D, Murphy DK. Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: 2-Year Results from a Pivotal Single-Blind Randomized Controlled Study. Dermatol Surg. 2013 Oct 4. doi: 10.1111/dsu.12343. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
April 2014
November 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00978042
VOLUMA-002
Not Provided
Allergan ( Allergan Medical )
Allergan Medical
Not Provided
Not Provided
Allergan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP