Restylane Defyne for Correction of Chin Retrusion

NCT03597256 | Completed Results

• 1 other identifier: 43CH1627
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chin Retrusion

Keywords

Hyaluronic acid; Chin Retrusion

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)

  GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.

  At Month 6

Secondary Outcomes (2)

• Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)

  Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatment

• Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator

  At Week 4 and Months 3, and 6

Study Arms (2)

Treatment Group

EXPERIMENTAL

Single injection and optional touch-up injection with Restylane Defyne in chin

Device: Restylane Defyne

Control Group

NO INTERVENTION

No treatment

Interventions

Restylane Defyne DEVICE

Intradermal injection

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participated with signed and dated informed consent form.
• Men or women aged 18 years of age or older of Chinese origin.
• Subjects who were seeking augmentation therapy for chin retrusion.
• GCRS score of 1 or 2 as assessed by the Blinded Evaluator

You may not qualify if:

• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
• Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
• History of severe or multiple allergies, manifested by anaphylaxis.
• 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.
• Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
• 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.
• Other condition that was 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Research Site

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• Xie Y, Zhao H, Wu W, Xu J, Li B, Wu S, Chen K, Bromee T, Li Q. Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study. Aesthetic Plast Surg. 2024 Mar;48(5):1030-1036. doi: 10.1007/s00266-023-03812-2. Epub 2024 Feb 5.

  PMID: 38315229 DERIVED

Results Point of Contact

• Title: Head of Development
• Organization: Q-Med AB

reception.seupp@galderma.com

+46184749000

Study Officials

• Q-Med AB

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: October 8, 2018
• Primary Completion: September 24, 2019
• Study Completion: September 9, 2020
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)