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

N/ANot Yet RecruitingNCT07805512

Galderma R&D162 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

162

Conditions

Jawline Definition

Interventions

Restylane Shaype

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.