A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-21

Study Completion Date

2020-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Restylane Defyne for Correction of Chin Retrusion

NCT03597256

Chin Retrusion

COMPLETED NA

Safety and Efficacy of Fillers for Contouring the Jawline

NCT06336759

Jawline Contour Deficit

COMPLETED NA

Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile

NCT05777759

Chin Augmentation Chin Retrusion

COMPLETED NA

Safety/Efficacy Study of Restylane® in Lip Augmentation

NCT00935272

Lip Augmentation

COMPLETED NA

Restylane Defyne in a Stepwise Treatment Approach

NCT04520997

Lower Face Folds and Lines

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion.

This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate).

Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject.

At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chin Retrusion Chin Augmentation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Restylane Defyne

injection with Restylane Defyne

Group Type EXPERIMENTAL

Restylane Defyne

Intervention Type DEVICE

hyaluronic acid dermal filler gel

Control

no-treatment control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Restylane Defyne

hyaluronic acid dermal filler gel

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion

Exclusion Criteria

* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
* Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes