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NCT Number: NCT07805512

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

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).

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Key information

Conditions

Jawline Definition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Investigational Site #6340

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Restylane Shaype

Device

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.

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 6 months after the last treatment for the Treatment group and at 6 months after baseline for the Control group.

    Responder rate based on the Blind Evaluators' live assessment using the Galderma Jawline Scale(GJS, a 5-grade scale ranging from none to severe Jawline definition deficiency).

    A responder is defined as ≥1 grade improvement on the GJS from baseline on both jawlines concurrently.

Secondary outcomes

  1. Secondary Outcome Measure

    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.

    Responder rate based on the Blinded Evaluators' live assessment using the GJS.

Study contacts

Contact information is provided by the study sponsor or research team.

Galderma Research & Development

CONTACT

[email protected]

+8621 23159790

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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