Restylane Shaype Versus Juvederm Volux for Chin Augmentation

NCT06336772 | Completed

• 1 other identifier: 10-2023-GAL-SHYP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin

Conditions

Chin Retrusion

Keywords

Chin Augmentation; Hyaluronic Acid Filler; Aesthetic Injection

Outcome Measures

Primary Outcomes (1)

• Statistically significant group differences in the average three-dimensional volumetric increase since baseline

  As assessed by the Canfield Vectra XT system.

  Baseline to Week 2, Week 4, Week 12, Week 24

Secondary Outcomes (3)

• Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale)

  Baseline to Week 2, Week 4, Week 12, Week 24

• Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale)

  Baseline to Week 2, Week 4, Week 12, Week 24

• Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues)

  Baseline to Week 2, Week 4, Week 12, Week 24

Study Arms (2)

Restylane Shaype

EXPERIMENTAL

Restylane Shaype is approved and commercially available for use in Canada and is manufactured by Q-Med AB, part of the Galderma Group. The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.

Device: Restylane Shaype

Juvederm Volux

ACTIVE COMPARATOR

Juvéderm Volux is approved and commercially available for use in Canada and is manufactured by Allergan Aesthetics, an Abbvie company. The participant will be treated at the Baseline visit and will be eligible for retreatment 2 weeks later if a touch up is deemed necessary by the Treating Investigator. Volumes used for each participant will be determined by the aesthetic judgement of the Treating Investigator.

Device: Juvéderm Volux

Interventions

Restylane Shaype DEVICE

Half (50%) of study participants will receive Restylane Shaype for the treatment of mild to severe chin retrusion

Restylane Shaype

Juvéderm Volux DEVICE

Half (50%) of study participants will receive Juvéderm Volux for the treatment of mild to severe chin retrusion

Juvederm Volux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of consent, male and female subjects 18 years of age and older.
• Patients with established chin retrusion at Baseline (a score of mild, moderate, and severe severity on the Galderma Chin Retrusion Scale).
• Accepted the obligation not to receive any other facial procedures throughout the study duration.
• Understood and accepted the obligation and would be logistically able to appear for all scheduled follow-up visits.
• No previous lower face fillers for 12 months prior to this study.
• Capable of providing informed consent.

You may not qualify if:

• Patients without chin retrusion at Baseline, per the Galderma Chin Retrusion Scale.
• Current Pregnancy or lactation \[sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)\].
• Hypersensitivity to Restylane or Juvéderm products, hyaluronic acid filler or amide local anesthetics.
• Patients presenting with porphyria or any other liver diseases.
• Inability to comply with follow-up and abstain from facial injections during the study period.
• Heavy smokers, classified as smoking more than 12 cigarettes per day.
• History of severe or multiple allergies manifested by anaphylaxis since drug allergies might preclude optimal management of complications.
• Previous tissue revitalization therapy in the treatment area (i.e., the lower face) within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion.
• Previous facial surgery, including liposuction.
• Lifetime history of permanent implants in the treatment region (i.e., the lower face)
• Lifetime history of semi-permanent dermal fillers in the treatment region (i.e., the lower face).
• History or presence of any disease or lesion near or at the treatment area, including inflammation, active or chronic infection, including in the mouth, dentals, head, and neck region.
• Active facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes zoster or any other facial condition that may increase the risk of cutaneous penetration of infective agents.
• Scars, deformities, piercings, or tattoos in the treatment areas.
• Facial cancer or precancer (e.g., actinic keratosis).

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc.

Montreal, Quebec, H3R3A1, Canada

Location

Study Officials

• Andreas Nikolis, MD

  Erevna Innovations Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: October 23, 2023
• Primary Completion: October 9, 2024
• Study Completion: November 9, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)