Jawline Definition
Conditions
Brief 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).
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.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A blind evaluator to assess study primary endpoint.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure | 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. |
Countries
China
Contacts
CONTACTGalderma Research & Development
STUDY_DIRECTORGalderma S.A.
Galderma S.A.
Outcome results
None listed