China Post-Market Clinical Follow-up of FACILLE®

NCT ID: NCT05294562

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1552 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-14
• Study Completion Date: 2020-05-12

Brief Summary

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.

Conditions

Dermal Filler; Hyaluronic Acid; Nasolabial Fold

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SciVision Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PMCF-FE01

Identifier Type: -

Identifier Source: org_study_id