Cheek AugmentationNCT04638816
Study to Evaluate Satisfaction After Treatment With Restylane
A study testing Restylane Volyme and Restylane Lyft Lidocaine in people with Cheek Augmentation, run by Galderma R&D at 3 sites in Canada.
Trial summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cheek Augmentation
- What is being tested?
- Restylane Volyme and Restylane Lyft Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 16 Apr 2021to 20 Aug 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent to participate in the study
- Adult women who intend to undergo cheek augmentation
Who cannot join
- Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
- Subjects with a previous implant other than HA in or near the intended treatment site
- Participation in any other clinical study within three (3) months before treatment
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Galderma Study Site
Montreal, Quebec
Galderma Study Site
Vancouver, British Columbia
Galderma Study Site
Woodbridge, Ontario
About this study
Official title: A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane
- Conditions
- Cheek Augmentation
- Being tested
- Restylane Volyme, Restylane Lyft Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane VolymeDevice
Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
Restylane Lyft LidocaineDevice
Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
| Study group | Role | What they receive |
|---|---|---|
| Restylane Volyme | Experimental | Hyaluronic Acid Receives: Device: Restylane Volyme |
| Restylane Lyft Lidocaine | Experimental | Hyaluronic Acid Receives: Device: Restylane Lyft Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Measured: 4 weeks after last treatment, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Apr 2021
- Primary completion3 Jul 2021
- Study completion20 Aug 2021
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 Cheek AugmentationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638816
- Sponsor's protocol ID
- 05DF2004
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2020
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane
- ClinicalTrials.gov ID
- NCT04638816
- Acronym / sponsor ID
- 05DF2004
- Conditions
- Cheek Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 3 Jul 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Volyme | Experimental | Device: Restylane VolymeHyaluronic Acid |
| Restylane Lyft Lidocaine | Experimental | Device: Restylane Lyft LidocaineHyaluronic Acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated informed consent to participate in the study
- Adult women who intend to undergo cheek augmentation
Key exclusion criteria (3 listed)
- Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
- Subjects with a previous implant other than HA in or near the intended treatment site
- Participation in any other clinical study within three (3) months before treatment
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 |
|---|---|---|
| Restylane VolymeHyaluronic Acid: Injectable gel for contouring effect (of cheek volumization). | Device | Restylane Volyme |
| Restylane Lyft LidocaineHyaluronic Acid: Injectable gel for projection effect (of cheek augmentation). | Device | Restylane Lyft Lidocaine |
Primary outcome
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Time frame: 4 weeks after last treatment, up to 6 weeks
The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cheek Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
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.
Study Director study director
Galderma R&D
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Volyme and Restylane Lyft Lidocaine in people with Cheek Augmentation, run by Galderma R&D at 3 sites in Canada.
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 2 inclusion and 3 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 6 Mar 2024). 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?
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS (time frame: 4 weeks after last treatment, up to 6 weeks). 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 6 Mar 2024.