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OpenTrials
Completed

NCT Number: NCT05294562

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.

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Key information

Conditions

Dermal Filler Hyaluronic Acid Nasolabial Fold

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Adverse events reported during the study period

    Time frame: 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 outcomes

  1. Subjects self-evaluating satisfaction

    Time frame: 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.

  2. Subjects self-evaluating effectiveness

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

    Patients rate their effectiveness based on effective and ineffective.

Sponsors and collaborators

Lead sponsor

SciVision Biotech Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Mar 24, 2022
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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