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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06336772
Other study ID # 10-2023-GAL-SHYP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 23, 2023
Est. completion date November 1, 2024

Study information

Verified date March 2024
Source Erevna Innovations Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date November 1, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Erevna Innovations Inc. Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Erevna Innovations Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) Baseline to Week 2, Week 4, Week 12, Week 24
Secondary 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) Baseline to Week 2, Week 4, Week 12, Week 24
Secondary 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. Baseline to Week 2, Week 4, Week 12, Week 24
See also
  Status Clinical Trial Phase
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Completed NCT04559984 - JUVÉDERM VOLUX® for Chin Retrusion in China Phase 3
Active, not recruiting NCT05777759 - Safety and Effectiveness of Restylane Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile N/A
Completed NCT02833077 - A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation N/A
Completed NCT04687046 - A Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults Using Real-World Evidence
Completed NCT02559908 - A Study of Hyaluronic Acid Injectable Gel (VYC-25L) for Restoration and Creation of Facial Volume in the Chin and Jaw N/A
Completed NCT03624816 - A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion N/A
Recruiting NCT05986630 - Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face N/A