CompletedNot Applicable

Restylane Shaype Versus Juvederm Volux for Chin Augmentation

Canada40 participantsStarted 2023-10-23

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

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

NCT IDNCT06336772

SponsorErevna Innovations Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-09

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.