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CompletedNCT06336772Updated Feb 4, 2025

Restylane Shaype Versus Juvederm Volux for Chin Augmentation

An interventional study of Restylane Shaype and Juvéderm Volux in Chin Retrusion, sponsored by Erevna Innovations Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Erevna Innovations Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chin Retrusion

Keywords

  • Chin Augmentation
  • Hyaluronic Acid Filler
  • Aesthetic Injection
03

In context

Lead sponsor

Erevna Innovations Inc. is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients without chin retrusion at Baseline, per the Galderma Chin Retrusion Scale.
  2. 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)].
  3. Hypersensitivity to Restylane or Juvéderm products, hyaluronic acid filler or amide local anesthetics.
  4. Patients presenting with porphyria or any other liver diseases.
  5. Inability to comply with follow-up and abstain from facial injections during the study period.
  6. Heavy smokers, classified as smoking more than 12 cigarettes per day.
  7. History of severe or multiple allergies manifested by anaphylaxis since drug allergies might preclude optimal management of complications.
  8. 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.
  9. Previous facial surgery, including liposuction.
  10. Lifetime history of permanent implants in the treatment region (i.e., the lower face)
  11. Lifetime history of semi-permanent dermal fillers in the treatment region (i.e., the lower face).
  12. 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.
  13. 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.
  14. Scars, deformities, piercings, or tattoos in the treatment areas.
  15. Facial cancer or precancer (e.g., actinic keratosis).
  16. History of radiation therapy in the treatment area.
  17. History of bleeding disorders, or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g., Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment.
  18. Patients with immune disorders such as systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease, and Hashimoto's thyroiditis, or subjects using immunosuppressants.
  19. Patients with a tendency to form hypertrophic or keloid scars, or any other healing disorders.
  20. Patients with a tendency to form post-inflammatory hyperpigmentation.
  21. Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anesthetics (e.g., certain anti-arrhythmics).
  22. Patients administered dental block or topical administration of lidocaine within 2 weeks of treatment.
  23. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
  24. Current remote infections (e.g., urinary tract, sinuses, intestinal tract, oral cavity)
  25. Planned dental procedures during the 2-week period before and after filler treatments, including teeth cleaning, tooth extraction and gum grafts.
  26. Planned COVID-19 vaccinations during the 2-week period before and after filler treatments.
  27. Lifetime history of cystic acne, due to increased risk of cyst development following filler treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Restylane Shaype

    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

  • Active comparator
    Juvederm Volux

    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

  • DeviceRestylane Shaype

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

  • DeviceJuvéderm Volux

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

06

What researchers measure

Primary outcomes

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

    As assessed by the Canfield Vectra XT system.

    Time frame: Baseline to Week 2, Week 4, Week 12, Week 24

Secondary outcomes

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

    The Galderma Chin Retrusion Scale is a 4 point Likert Scale used to assess chin retrusion ranging from "no retrusion" (grade 0) to "severe retrusion" (grade 3)

    Time frame: Baseline to Week 2, Week 4, Week 12, Week 24

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

    The Global Aesthetic Improvement Scale is a 5 point Likert Scale in which the blinded investigator can assess change in chin retrusion following aesthetic treatment. The grading scale ranges from "worse" (grade -1) to "very much improved" (grade 3)

    Time frame: Baseline to Week 2, Week 4, Week 12, Week 24

  3. 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)

    This will be done by means of measurement of the radius or surface area of in vivo product placed within tissues, integration \[or lack thereof\] of the product into the surrounding tissues.

    Time frame: Baseline to Week 2, Week 4, Week 12, Week 24

07

Study locations

1 site
  • Erevna Innovations Inc.
    Montréal, Quebec H3R3A1, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06336772
Lead sponsor
Erevna Innovations Inc.
Responsible party
Sponsor
First posted
Mar 29, 2024
Start date
Oct 23, 2023
Primary completion
Oct 9, 2024
Completion
Nov 9, 2024
Last update
Feb 4, 2025

Study contacts

Andreas Nikolis, MD
principal investigator · Erevna Innovations Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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