China Post-Market Clinical Follow-up of FACILLE®

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Fold; Hyaluronic Acid; Dermal Filler

• Study Type: Observational
• Enrollment (Actual): 1552

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Institution of Medical Cosmetology

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events reported during the study period	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.	36 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SciVision Biotech Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2016
• Primary Completion (ACTUAL): May 7, 2017
• Study Completion (ACTUAL): May 12, 2020

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (ACTUAL): March 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PMCF-FE01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No