AgingNCT02437903
Open Label Study Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
A study testing JUVÉDERM VOLUMA™ XC in people with Aging, run by Baumann Cosmetic and Research Institute at 1 site in United States.
Trial summary
This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2015to 5 Apr 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to read and sign the informed consent and other study documents.
- Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale.
- Written informed consent has been obtained prior to any study-related procedures.
- Written Authorization for Use and Release of Health and Research Study Information has been signed.
- Ability to follow study instructions and complete study assessment tools including the subject diary
- Female patients of childbearing potential must have a negative urine pregnancy test result and not be lactating.
- Likely to complete all required visits with no plans to move from Miami in the next 12 months
- Agree to not undergo other treatments or cosmetic procedures in the treatment area during the study such as facial laser treatments, botulinum toxin, hyaluronic acid injections, subcutaneous fat injections, any other permanent or semi-permanent facial fillers.
Who cannot join
- Any uncontrolled systemic disease
- History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease.
- Have a history of severe allergic/anaphylactic reactions or multiple allergies.
- Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma.
- Females planning to become pregnant, are pregnant, or are breast-feeding.
- History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit
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- Have severe thin skin, in the treatment area as determined by the PI.
- Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months in the treatment area. Have had neuromodulator injections, mesotherapy, or resurfacing (laser or other ablative or non-ablative procedures) within 5 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study.
- Have undergone facial plastic surgery (with the exception of rhinoplasty or a brow lift), 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 affecting the treatment area, at any time during the study.
- Unwilling to undergo injections in the temple area.
- Have a history of migraines or frequent headaches, as determined by the PI.
- Have blindness or partial vision loss in either eye.
- Have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations.
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
- Patient who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
- Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g.,warfarin), anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 10 days pre- to 3 days post injection. A wash out period of 10 days is allowed.
- Have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
About this study
Official title: Open Label, Single-center Study, Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.
Read the detailed description
Volume deficit in the temporal area (the side of the forehead) of the face is a common sign of aging.
JUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area.
JUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation, produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal injection.
JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12 months.
- Conditions
- Aging
- Being tested
- JUVÉDERM VOLUMA™ XC
- Keywords
- voluma temporal, facial, volume loss
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM VOLUMA™ XCDevice
Also called Injectable Dermal Filler
Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM VOLUMA™ XC | Other | Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. Receives: Device: JUVÉDERM VOLUMA™ XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal Temporal Fossa Rating Scale
Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.
Measured: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Secondary outcomes (1)
Investigator's Satisfaction With the Appearance of the Temporal Regions
Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side.
Measured: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start7 Aug 2015
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
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 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baumann Cosmetic and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie S Baumann, MD,CPI, Principal investigator, Baumann Cosmetic and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437903
- Sponsor's protocol ID
- Voluma Temporal 2014
- Status last verified
- Jan 2018
- First submitted
- 30 Apr 2015
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single-center Study, Evaluating the Efficacy and Safety of JUVÉDERM VOLUMA™ XC for the Facial Temporal Regions
- ClinicalTrials.gov ID
- NCT02437903
- Acronym / sponsor ID
- Voluma Temporal 2014
- Conditions
- Aging
- Keywords
- voluma temporal, facial, volume loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baumann Cosmetic and Research InstituteUniversity, hospital or other
- Study start
- 7 Aug 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine the efficacy and safety of JUVÉDERM VOLUMA™ XC when used in the facial temporal regions based on the change in the score of the investigator's Temporal. This study will be an open label, single center study.
Detailed description
Volume deficit in the temporal area (the side of the forehead) of the face is a common sign of aging.
JUVÉDERM VOLUMA™ XC is a dermal filler, which was FDA-approved in October 2013 for the improvement and correction of age-related volume deficit in the mid-face area.
JUVÉDERM VOLUMA™ XC is a gel implant composed of 20 mg/mL hyaluronic acid (HA) formulation, produced by Streptococcus equi bacteria, and 0.3 w/w lidocaine. JUVÉDERM VOLUMA™ XC is a clear, sterile, and biodegradable gel indicated for subcutaneous and/or supraperiosteal injection.
JUVÉDERM VOLUMA™ XCwill be injected in the temple area and subjects will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM VOLUMA™ XC | Other | Device: JUVÉDERM VOLUMA™ XCSubjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to read and sign the informed consent and other study documents.
- Treating investigator's score of 3, 4, or 5 on the Temporal Fossa Rating Scale.
- Written informed consent has been obtained prior to any study-related procedures.
- Written Authorization for Use and Release of Health and Research Study Information has been signed.
- Ability to follow study instructions and complete study assessment tools including the subject diary
Key exclusion criteria (17 listed)
- Any uncontrolled systemic disease
- History of any of the following conditions: vision loss not corrected by lenses or LASIX surgery; glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease.
- Have a history of severe allergic/anaphylactic reactions or multiple allergies.
- Conditions within the treatment area including acne, scarring, acute lupus erythematosus, dermatitis, or melasma.
- Females planning to become pregnant, are pregnant, or are breast-feeding.
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™ XCAlso: Injectable Dermal FillerSubjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12. | Device | JUVÉDERM VOLUMA™ XC |
Primary outcome
Frontal Temporal Fossa Rating Scale
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.
1 secondary outcome
Investigator's Satisfaction With the Appearance of the Temporal Regions
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leslie S Baumann, MD,CPI principal investigator
Baumann Cosmetic and Research Institute
1 site 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 in people with Aging, run by Baumann Cosmetic and Research Institute at 1 site 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 8 inclusion and 17 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 16 May 2017). 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?
Frontal Temporal Fossa Rating Scale (time frame: Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12). 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 15 Feb 2018.