Jawline DefinitionNCT07805512
A Study to Evaluate the Effectiveness and Safety of Restylane Shaype in the Improvement of Jawline Definition
A study testing Restylane Shaype in people with Jawline Definition, run by Galderma R&D at 6 sites in China.
Trial summary
This is a randomized, evaluator-blinded, parallel group, no-treatment controlled, multicenter study to evaluate effectiveness and the safety of Restylane Shaype for improvement of jawline definition in China. Subjects of Chinese origin, age 18 years, who are eligible for treatment to improve jawline definition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jawline Definition
- What is being tested?
- Restylane Shaype
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 6 sitesChina
- Study dates
- 28 Sep 2026to Mar 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
- No healthy volunteers
- 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 receive bilateral jawline definition 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.
- Previous or present multiple allergies or severe allergies, such as manifested by 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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Galderma Investigational Site #6340
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Galderma Investigational Site #6345
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Galderma Investigational Site #6540
Beijing, Beijing Municipality, 100000
- Not yet recruiting
Galderma Investigational Site #6347
Chengdu, Sichuan, 610000
- Recruiting
Galderma Investigational Site #6547
Hangzhou, Zhejiang, 310000
- Recruiting
Galderma Investigational Site #6601
Nanjing, Jiangsu, 210000
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane® Shaype™ for Improvement of Jawline Definition in Chinese Subjects
This is a randomized, evaluator-blinded, parallel group, no-treatment controlled, multicenter study to evaluate effectiveness and the safety of Restylane Shaype for improvement of jawline definition in China. Subjects of Chinese origin, age 18 years, who are eligible for treatment to improve jawline definition. Study sites is approximately 6.
A total of approximately 162 subjects will be randomized (2:1) to either treatment with Restylane Shaype Treatment Group (approximately 108subjects) or no-treatment Control Group (approximately 54 subjects).
- Conditions
- Jawline Definition
- Being tested
- Restylane Shaype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane ShaypeDevice
Restylane Shaype is an injectable, sterile, transparent, biodegradable gel of non-animal crosslinked sodium hyaluronate. Restylane Shaype has the addition of lidocaine hydrochloride. They are supplied in a glass syringe.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Restylane Shaype Subjects in the Treatment Group will be treated with Restylane Shaype at Baseline, Week 4(optional touch-up). Receives: Device: Restylane Shaype |
| Control group | No intervention | No treatment Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate based on the Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS) .
A responder is defined as ≥1 grade improvement on the GJS from baseline on both jawlines concurrently.
GJS is a 5-grade scale ranging from none to severe Jawline definition deficiency.
Measured: At 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.
Secondary outcomes (1)
Responder rate based on the Blinded Evaluators' live assessment using the GJS
Measured: At 3, 9 and 12 months after last treatment for Treatment group and at 3 months after baseline, as well as at 3 and 6 months after optional treatment for the Control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start28 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jawline DefinitionStudies 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
- 162 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
- NCT07805512
- Sponsor's protocol ID
- 43BBCH2508
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane® Shaype™ for Improvement of Jawline Definition in Chinese Subjects
- ClinicalTrials.gov ID
- NCT07805512
- Acronym / sponsor ID
- 43BBCH2508
- Conditions
- Jawline Definition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Sep 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, no-treatment controlled, multicenter study to evaluate effectiveness and the safety of Restylane Shaype for improvement of jawline definition in China. Subjects of Chinese origin, age 18 years, who are eligible for treatment to improve jawline definition. Study sites is approximately 6.
A total of approximately 162 subjects will be randomized (2:1) to either treatment with Restylane Shaype Treatment Group (approximately 108subjects) or no-treatment Control Group (approximately 54 subjects).
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: Restylane ShaypeRestylane Shaype Subjects in the Treatment Group will be treated with Restylane Shaype at Baseline, Week 4(optional touch-up). |
| Control group | No intervention | –No treatment Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 receive bilateral jawline definition 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.
- Previous or present multiple allergies or severe allergies, such as manifested by 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 |
|---|---|---|
| Restylane ShaypeRestylane Shaype is an injectable, sterile, transparent, biodegradable gel of non-animal crosslinked sodium hyaluronate. Restylane Shaype has the addition of lidocaine hydrochloride. They are supplied in a glass syringe. | Device | Treatment Group |
Primary outcome
Responder rate based on the Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS) .
Time frame: At 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.
A responder is defined as ≥1 grade improvement on the GJS from baseline on both jawlines concurrently. GJS is a 5-grade scale ranging from none to severe Jawline definition deficiency.
1 secondary outcome
Responder rate based on the Blinded Evaluators' live assessment using the GJS
Time frame: At 3, 9 and 12 months after last treatment for Treatment group and at 3 months after baseline, as well as at 3 and 6 months after optional treatment for the Control group.
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Shaype in people with Jawline Definition, run by Galderma R&D at 6 sites 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: looking for participants now, as of the sponsor's last update on 3 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 6 sites 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 Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS) . (time frame: At 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.). 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 3 Nov 2026.