Restylane Defyne for Correction of Chin Retrusion

A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.

Study Overview

• Status: Completed
• Conditions: Chin Retrusion
• Intervention / Treatment: Device: Restylane Defyne

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Q-Med AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed and dated informed consent to participate in the study.
2. Men or women aged 18 years of age or older of Chinese origin.
3. Subjects seeking augmentation therapy for chin retrusion.
4. GCRS score of 1 or 2 as assessed by the Blinded Evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
3. History of severe or multiple allergies, manifested by anaphylaxis.
4. Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
6. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
7. Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No treatment
Experimental: Treatment Group; Single injection and optional touch-up injection with Restylane Defyne in chin	Device: Restylane Defyne; Intradermal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GCRS(Galderma Chin Retrusion Scale) at 6 months	1 point improvement from baseline on the GCRS as measured by the Blinded Evaluator at 6 months (after last treatment in Treatment Group, and after randomization in Control Group)	6 month

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Hyaluronic acid; Chin Retrusion
• Other Study ID Numbers: 43CH1627

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No