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

Galderma

Status: Completed

Conditions: Chin Augmentation; Chin Retrusion

Treatments: Device: Restylane Defyne

Study type: Interventional

Funder types: Industry

Identifiers

NCT03624816

43USCH1702

Details and patient eligibility

About

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.

Full description

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

Enrollment: 140 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Restylane Defyne

Experimental group

Description:

injection with Restylane Defyne

Treatment:

Device: Restylane Defyne

Control

No Intervention group

Description:

no-treatment control