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

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).

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:

1. Known/previous allergy or hypersensitivity 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.