Cheek WrinklesNCT07909421
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
A study testing GP0112 and Juvéderm Voluma XC in people with Cheek Wrinkles and Midface Contour Deficiencies, run by Galderma R&D at 1 site in China.
Trial summary
This is a randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cheek Wrinkles, Midface Contour Deficiencies
- What is being tested?
- GP0112 and 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
- 326 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.
- Intent to undergo cheek augmentation or correction of midface contour deficiencies treatment.
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics or nerve blocking agents.
- Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
- Prior surgery in the treatment area that in the Treatment investigator's opinion could interfere with the study safety and/or effectiveness assessments.
- Any previous aesthetic procedures or implants.
- Presence of any disease or lesions near or in the area to be treated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
This is a randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies.
Approximately 326 subjects will be randomized (1:1) to either treatment with GP0112 or Juvéderm Voluma XC(also known as Juvéderm Voluma with lidocaine).
- Conditions
- Cheek Wrinkles, Midface Contour Deficiencies
- Being tested
- GP0112, Juvéderm Voluma XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP0112Device
Injectable gel
Juvéderm Voluma XCDevice
Injectable gel
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single injection and optional touch-up injection with GP0112 Receives: Device: GP0112 |
| Control Group | Active comparator | Single injection and optional touch-up injection with Juvéderm Voluma XC Receives: Device: Juvéderm Voluma XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate based on the Blinded Evaluators' live assessment using the Medicis Midface Volume Scale (MMVS).
A responder is defined as a subject with at least 1 grade improvement from baseline on both sides of the face concurrently.
Measured: At Month 6 after last treatment.
Secondary outcomes (1)
Responder rate based on the Blinded Evaluator's live assessment of the MMVS.
Measured: At Months 1, 3, 9 and 12 after last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cheek WrinklesStudies 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
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galderma S.A., Study director, Galderma S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909421
- Sponsor's protocol ID
- 43N1CH2501
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
- ClinicalTrials.gov ID
- NCT07909421
- Acronym / sponsor ID
- 43N1CH2501
- Conditions
- Cheek Wrinkles, Midface Contour Deficiencies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies.
Approximately 326 subjects will be randomized (1:1) to either treatment with GP0112 or Juvéderm Voluma XC(also known as Juvéderm Voluma with lidocaine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: GP0112Single injection and optional touch-up injection with GP0112 |
| Control Group | Active comparator | Device: Juvéderm Voluma XCSingle injection and optional touch-up injection with Juvéderm Voluma XC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.
- Intent to undergo cheek augmentation or correction of midface contour deficiencies treatment.
Key exclusion criteria (6 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics or nerve blocking agents.
- Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
- Prior surgery in the treatment area that in the Treatment investigator's opinion could interfere with the study safety and/or effectiveness assessments.
- Any previous aesthetic procedures or implants.
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 |
|---|---|---|
| GP0112Injectable gel | Device | Treatment Group |
| Juvéderm Voluma XCInjectable gel | Device | Control Group |
Primary outcome
Responder rate based on the Blinded Evaluators' live assessment using the Medicis Midface Volume Scale (MMVS).
Time frame: At Month 6 after last treatment.
A responder is defined as a subject with at least 1 grade improvement from baseline on both sides of the face concurrently.
1 secondary outcome
Responder rate based on the Blinded Evaluator's live assessment of the MMVS.
Time frame: At Months 1, 3, 9 and 12 after last treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Galderma S.A. study director
Galderma S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP0112 and Juvéderm Voluma XC in people with Cheek Wrinkles and Midface Contour Deficiencies, run by Galderma R&D at 1 site in China.
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 6 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: opening soon, as of the sponsor's last update on 2 Nov 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galderma Research & Development (+8621 23159790, Clinical.Studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate based on the Blinded Evaluators' live assessment using the Medicis Midface Volume Scale (MMVS). (time frame: At Month 6 after last treatment.). 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 2 Nov 2026.