China Post-Market Clinical Follow-up of FACILLE®

Completed

• Conditions: Dermal Filler; Nasolabial Fold; Hyaluronic Acid

• Registration Number: NCT05294562
• Lead Sponsor: SciVision Biotech Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-14
• Primary Completion: 2017-05-07
• Study Completion: 2020-05-12
• Status Verified: 2022-03
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1552

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events reported during the study period	36 months	The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.

Secondary Outcome Measures

Name	Time	Method
Subjects self-evaluating satisfaction	2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection	Patients rate their treatment satisfaction based on highly satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied.
Subjects self-evaluating effectiveness	2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection	Patients rate their effectiveness based on effective and ineffective.