China Post-Market Clinical Follow-up of FACILLE®

SciVision Biotech

Status: Completed

Conditions: Dermal Filler; Hyaluronic Acid; Nasolabial Fold

Study type: Observational

Funder types: Industry

Identifiers

NCT05294562

PMCF-FE01

Details and patient eligibility

About

The results showed that subjects tolerated the Sodium Hyaluronate Gel for Injection (FACILLE®) well, with no systemic AEs, SAEs, and unanticipated AEs and associated with high satisfaction and self-evaluated effectiveness. Nearly half of the subjects maintained correction for 12 months and were satisfied with the product 3 years after the first injection.

Enrollment: 1,552 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 years or older of male or female;
• Have used or plan to use FACILLE® Sodium Hyaluronate Gel for Injection;
• Agree to participate and comply with the follow-up schedule of this study.

Exclusion criteria

• With a history of hypersensitivity or allergy to hyaluronic acid or any component of the device;
• Other circumstances were judged to be unsuitable for participating in the study by the investigator.