Age-related Volume Deficit in the Mid-faceNCT03438266
A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
A study testing JUVÉDERM VOLUMA® XC injectable gel with cannula and JUVÉDERM VOLUMA® XC injectable gel with needle in people with Age-related Volume Deficit in the Mid-face, run by Allergan at 7 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Age-related Volume Deficit in the Mid-face
- What is being tested?
- JUVÉDERM VOLUMA® XC injectable gel with cannula and JUVÉDERM VOLUMA® XC injectable gel with needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Feb 2018to 2 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Mid-Face Volume Deficit Scale (MFVDS);
Who cannot join
- 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 anesthetics), hyaluronic acid (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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Aesthetic Solutions, PA
Chapel Hill, North Carolina, 27517
Skin Laser & Surgery Specialists of NY/NJ
Hackensack, New Jersey, 07601
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, 90069
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
Art of Skin MD
Solana Beach, California, 92075
Saint Louis University Dermatology
St Louis, Missouri, 63122
Rhoda S. Narins, MD, PC
White Plains, New York, 10604
About this study
Official title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.
- Being tested
- JUVÉDERM VOLUMA® XC injectable gel with cannula, JUVÉDERM VOLUMA® XC injectable gel with needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM VOLUMA® XC injectable gel with cannulaDevice
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
JUVÉDERM VOLUMA® XC injectable gel with needleDevice
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel with Cannula | Experimental | Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula. Receives: Device: JUVÉDERM VOLUMA® XC injectable gel with cannula |
| JUVÉDERM VOLUMA® XC Injectable Gel with Needle | Other | Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. Receives: Device: JUVÉDERM VOLUMA® XC injectable gel with needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score
The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.
Measured: Baseline (Screening) to Month 1
Secondary outcomes (3)
Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score
The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.
Measured: Baseline (Screening) to Month 1
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score
The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.
Measured: Baseline (Screening) to Month 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start5 Feb 2018
- Primary completion29 May 2018
- Study completion2 Aug 2018
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.
- Other trials for Age-related Volume Deficit in the Mid-faceStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Abrams, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438266
- Sponsor's protocol ID
- 1650-801-008
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2018
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
- ClinicalTrials.gov ID
- NCT03438266
- Acronym / sponsor ID
- 1650-801-008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM VOLUMA® XC Injectable Gel with Cannula | Experimental | Device: JUVÉDERM VOLUMA® XC injectable gel with cannulaParticipants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula. |
| JUVÉDERM VOLUMA® XC Injectable Gel with Needle | Other | Device: JUVÉDERM VOLUMA® XC injectable gel with needleParticipants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 Mid-Face Volume Deficit Scale (MFVDS);
Key exclusion criteria (4 listed)
- 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 anesthetics), hyaluronic acid (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.
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® XC injectable gel with cannulaParticipants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula. | Device | JUVÉDERM VOLUMA® XC Injectable Gel with Cannula |
| JUVÉDERM VOLUMA® XC injectable gel with needleParticipants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle. | Device | JUVÉDERM VOLUMA® XC Injectable Gel with Needle |
Primary outcome
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score
Time frame: Baseline (Screening) to Month 1
The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.
3 secondary outcomes
Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score
Time frame: Baseline (Screening) to Month 1
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score
Time frame: Baseline (Screening) to Month 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Steve Abrams study director
Allergan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVÉDERM VOLUMA® XC injectable gel with cannula and JUVÉDERM VOLUMA® XC injectable gel with needle in people with Age-related Volume Deficit in the Mid-face, run by Allergan at 7 sites in United States.
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 1 inclusion and 4 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 5 Aug 2019). 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?
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score (time frame: Baseline (Screening) to Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2019.