Cheek AugmentationNCT03700047
GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
A study testing GAL1704 and Juvederm Voluma in people with Cheek Augmentation, run by Galderma R&D at 15 sites in United States.
Trial summary
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cheek Augmentation
- What is being tested?
- GAL1704 and Juvederm Voluma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 15 sitesUnited States
- Study dates
- 18 Oct 2018to 22 May 2020
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.
Who cannot join
- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Galderma Study Site
Baltimore, Maryland, 21208
Galderma study site
Bellaire, Texas, 77401
Galderma study site
Charleston, South Carolina, 29414
Galderma Study Site
Chestnut Hill, Massachusetts, 02467
Galderma Study site
Dallas, Texas, 75254
Galderma Study site
Los Angeles, California, 90069
Galderma Study Site
Miami, Florida, 11137
Galderma Study Site
Mount Kisco, New York, 10549
Galderma Study Site
New Orleans, Louisiana, 70115
Galderma Study Site
New York, New York, 10021
Galderma Study Site
New York, New York, 10028
Galderma Study Site
Sacramento, California, 95816
Galderma Study Site
Salt Lake City, Utah, 84101
Galderma Study Site
Solana Beach, California, 92075
Galderma Study Site
West Palm Beach, Florida, 33401
About this study
Official title: A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.
- Conditions
- Cheek Augmentation
- Being tested
- GAL1704, Juvederm Voluma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAL1704Device
new dermal filler
Juvederm VolumaDevice
hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| GAL1704 (needle) | Experimental | Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies. Receives: Device: GAL1704 |
| GAL1704 (cannula/needle) | Experimental | GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle. Receives: Device: GAL1704 |
| Juvederm Voluma | Active comparator | Subjects randomized to control. Receives: Device: Juvederm Voluma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start18 Oct 2018
- Primary completion10 Jun 2019
- Study completion22 May 2020
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700047
- Sponsor's protocol ID
- 43USV1704
- Status last verified
- May 2022
- First submitted
- 4 Oct 2018
- Last updated
- 26 Aug 2022
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
- ClinicalTrials.gov ID
- NCT03700047
- Acronym / sponsor ID
- 43USV1704
- Conditions
- Cheek Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GAL1704 (needle) | Experimental | Device: GAL1704Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies. |
| GAL1704 (cannula/needle) | Experimental | Device: GAL1704GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle. |
| Juvederm Voluma | Active comparator | Device: Juvederm VolumaSubjects randomized to control. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.
Key exclusion criteria (1 listed)
- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit
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 |
|---|---|---|
| GAL1704new dermal filler | Device | GAL1704 (cannula/needle), GAL1704 (needle) |
| Juvederm Volumahyaluronic acid | Device | Juvederm Voluma |
Primary outcome
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
Time frame: 12 weeks
Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.
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 Cheek Augmentation
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAL1704 and Juvederm Voluma in people with Cheek Augmentation, run by Galderma R&D at 15 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 1 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 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 15 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 31 May 2022). 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 Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) (time frame: 12 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 26 Aug 2022.