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).
Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.
Intent to receive bilateral jawline definition treatment.
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.
Parallel
Restylane Shaype
DeviceRestylane 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.
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.
Responder rate based on the Blinded Evaluators' live assessment using the GJS
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
