Mid-facial Volume Deficit Related to AgingNCT00978042
Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
A study testing Juvéderm® VOLUMA XC in people with Mid-facial Volume Deficit Related to Aging, run by Allergan at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mid-facial Volume Deficit Related to Aging
- What is being tested?
- Juvéderm® VOLUMA XC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Being tested
- Juvéderm® VOLUMA XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvéderm® VOLUMA XCDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VOLUMA® XC Treatment Arm | Experimental | 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. Receives: Device: Juvéderm® VOLUMA XC |
| Control Arm_No Treatment then VOLUMA® XC | Other | 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. Receives: Device: Juvéderm® VOLUMA XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)
The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant'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.
Measured: 6 months
Secondary outcomes (3)
Duration of Treatment Effect
Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall 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).
Measured: 24 Months
Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)
The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.
Measured: 6 months
Responder Rate Based on Improvement in Score on MFVDS by Facial Region
The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant's respective mid-facial area 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. The percentage of responders is categorized by facial region.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mid-facial Volume Deficit Related to AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978042
- Sponsor's protocol ID
- VOLUMA-002
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2009
- Last updated
- 3 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 24093664Few 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.
PubMed 25964628
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation
- ClinicalTrials.gov ID
- NCT00978042
- Acronym / sponsor ID
- VOLUMA-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Posted 13 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOLUMA® XC Treatment Arm | Experimental | Device: Juvéderm® VOLUMA XCParticipants 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. |
| Control Arm_No Treatment then VOLUMA® XC | Other | Device: Juvéderm® VOLUMA XCNo 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juvéderm® VOLUMA XCTreating 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. | Device | Control Arm_No Treatment then VOLUMA® XC, VOLUMA® XC Treatment Arm |
Primary outcome
Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)
Time frame: 6 months
The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a "responder," the average of the blinded, independent Evaluating Investigators' assessments of the participant'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.
3 secondary outcomes
Duration of Treatment Effect
Time frame: 24 Months
Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)
Time frame: 6 months
Responder Rate Based on Improvement in Score on MFVDS by Facial Region
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24093664Jones 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.
- Derived from this study: PubMed 25964628Few 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juvéderm® VOLUMA XC in people with Mid-facial Volume Deficit Related to Aging, run by Allergan at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00978042, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.