China Post-Market Clinical Follow-up of FACILLE®

NCT05294562 | Completed

• 1 other identifier: PMCF-FE01
• Study Type: observational
• Target: 1,552
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjects self-evaluating satisfaction

  2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection

• Subjects self-evaluating effectiveness

  2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Institution of Medical Cosmetology

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SciVision Biotech Inc.: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 24, 2022
• Study Start: December 14, 2016
• Primary Completion: May 7, 2017
• Study Completion: May 12, 2020
• Last Updated: March 24, 2022

Record last verified: 2022-03