Facial Tissue AugmentationNCT02396251
Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation
A study testing HA experimental and HA comparator in people with Facial Tissue Augmentation, run by Galderma R&D at 2 sites in Sweden.
Trial summary
A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Tissue Augmentation
- What is being tested?
- HA experimental and HA comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesSweden
- Study dates
- 28 Feb 2015to 14 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide a signed and dated informed consent to participate in the study including release of copyright of images
- Man or woman aged 18 years or older
- Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable HA gel
- History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
- Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
- Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
- The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multi-Centre, Evaluator-Blinded Study to Evaluate Efficacy and Safety of R Volumizer for Cheek Augmentation
A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.
- Conditions
- Facial Tissue Augmentation
- Being tested
- HA experimental, HA comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA experimentalDevice
HA comparatorDevice
| Study group | Role | What they receive |
|---|---|---|
| HA experimental | Experimental | HA experimental only Receives: Device: HA experimental |
| HA comparator | Active comparator | HA experimental + HA comparator Receives: Device: HA experimental; Device: HA comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders in Midface Fullness Using Photo Scale
Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
Measured: 3 months
Secondary outcomes (1)
Percentage of Responders in Midface Fullness Using Photo Scale
Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start28 Feb 2015
- Primary completion19 Dec 2016
- Study completion14 Nov 2017
Why it stopped: Sponsor business reasons
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 Facial Tissue AugmentationStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396251
- Sponsor's protocol ID
- 43VZ1407
- Status last verified
- Sep 2019
- First submitted
- 27 Feb 2015
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Evaluator-Blinded Study to Evaluate Efficacy and Safety of R Volumizer for Cheek Augmentation
- ClinicalTrials.gov ID
- NCT02396251
- Acronym / sponsor ID
- 43VZ1407
- Conditions
- Facial Tissue Augmentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business reasons
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2015 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA experimental | Experimental | Device: HA experimentalHA experimental only |
| HA comparator | Active comparator | Device: HA experimental, Device: HA comparatorHA experimental + HA comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide a signed and dated informed consent to participate in the study including release of copyright of images
- Man or woman aged 18 years or older
- Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area
Key exclusion criteria (5 listed)
- Known/previous allergy or hypersensitivity to any injectable HA gel
- History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
- Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
- Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
- The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason
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 |
|---|---|---|
| HA experimental | Device | HA comparator, HA experimental |
| HA comparator | Device | HA comparator |
Primary outcome
Percentage of Responders in Midface Fullness Using Photo Scale
Time frame: 3 months
Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
1 secondary outcome
Percentage of Responders in Midface Fullness Using Photo Scale
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Facial Tissue Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
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.
Q-Med AB study director
Galderma R&D
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA experimental and HA comparator in people with Facial Tissue Augmentation, run by Galderma R&D at 2 sites in Sweden.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 26 Aug 2022. 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 Sweden. 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 1 Oct 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?
Percentage of Responders in Midface Fullness Using Photo Scale (time frame: 3 months). 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 26 Aug 2022.