China Post-Market Clinical Follow-up of FACILLE®

Hyaluronic Acid Clinical Trial

Official title:

China Post-Market Clinical Follow-up of FACILLE®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294562
• Other study ID #: PMCF-FE01
• Status: Completed
• Start date: December 14, 2016
• Est. completion date: May 12, 2020

Study information

• Verified date: March 2022
• Source: SciVision Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1552
• Est. completion date: May 12, 2020
• Est. primary completion date: May 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermal Filler
• Hyaluronic Acid
• Nasolabial Fold

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SciVision Biotech Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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