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

NCT ID: NCT00978042

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-04-30

Brief Summary

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.

Conditions

Mid-facial Volume Deficit Related to Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

VOLUMA® XC Treatment Arm

Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.

Group Type: EXPERIMENTAL

Juvéderm® VOLUMA XC

Intervention Type: DEVICE

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.

Control Arm_No Treatment then VOLUMA® XC

No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.

Group Type: OTHER

Juvéderm® VOLUMA XC

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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 Non-Steroidal Anti-Inflammatory Drugs (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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Los Angeles, California, United States

Vancouver, British Columbia, Canada

Countries

United States; Canada

References

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 Nov;39(11):1602-12. doi: 10.1111/dsu.12343. Epub 2013 Oct 4.

Reference Type: RESULT

PMID: 24093664 (View on PubMed)

Few J, Cox SE, Paradkar-Mitragotri D, Murphy DK. A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.

Reference Type: DERIVED

PMID: 25964628 (View on PubMed)

Other Identifiers

VOLUMA-002

Identifier Type: -

Identifier Source: org_study_id