ClinicalTrials.gg
RecruitingNCT07805512Updated Nov 3, 2026

A Study to Evaluate the Effectiveness and Safety of Restylane Shaype in the Improvement of Jawline Definition

An interventional study of Restylane Shaype in Jawline Definition, sponsored by Galderma R&D. Recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 3, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Jawline Definition
03

In context

Lead sponsor

Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.
  2. Intent to receive bilateral jawline definition treatment.

Exclusion criteria

Exclusion Criteria:

  1. Known/previous allergy or to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
  2. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
  3. Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
  4. Prior surgery in the treatment area that in the Treatment investigator's opinion could interfere with the study safety and/or effectiveness assessments.
  5. Any previous aesthetic procedures or implants.
  6. Presence of any disease or lesions near or in the area to be treated.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Restylane Shaype Subjects in the Treatment Group will be treated with Restylane Shaype at Baseline, Week 4(optional touch-up).

    Device: Restylane Shaype

  • No intervention
    Control group

    No treatment Control Group

Interventions

  • DeviceRestylane Shaype

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    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.

07

Study locations

2 of 6 sites recruiting
  • Galderma Investigational Site #6340
    Beijing, Beijing Municipality 100000, China
    Not yet recruiting
  • Galderma Investigational Site #6345
    Beijing, Beijing Municipality 100000, China
    Not yet recruiting
  • Galderma Investigational Site #6540
    Beijing, Beijing Municipality 100000, China
    Not yet recruiting
  • Galderma Investigational Site #6601
    Nanjing, Jiangsu 210000, China
    Recruiting
  • Galderma Investigational Site #6347
    Chengdu, Sichuan 610000, China
    Not yet recruiting
  • Galderma Investigational Site #6547
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 4, 2026
StartActual
Sep 28, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Mar 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
5 sites added. Galderma Investigational Site #6340 is now Not yet recruiting
Show 5 added (5 China)
  • Galderma Investigational Site #6345 · Beijing, China
  • Galderma Investigational Site #6540 · Beijing, China
  • Galderma Investigational Site #6601 · Nanjing, China
  • Galderma Investigational Site #6347 · Chengdu, China
  • Galderma Investigational Site #6547 · Hangzhou, China
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    5 sites added. Galderma Investigational Site #6340 is now Not yet recruiting
    Show 5 added (5 China)
    • Galderma Investigational Site #6345 · Beijing, China
    • Galderma Investigational Site #6540 · Beijing, China
    • Galderma Investigational Site #6601 · Nanjing, China
    • Galderma Investigational Site #6347 · Chengdu, China
    • Galderma Investigational Site #6547 · Hangzhou, China
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07805512
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Sep 28, 2026
Primary completion
Sep 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Galderma Research & Development
Contact
Clinical.Studies@galderma.com
+8621 23159790
Galderma S.A.
study director · Galderma S.A.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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