Dermal FillerNCT05294562
China Post-Market Clinical Follow-up of FACILLE®
An observational study of Dermal Filler and Hyaluronic Acid, run by SciVision Biotech Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dermal Filler, Hyaluronic Acid, Nasolabial Fold
- How many people
- 1,552 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2016to 12 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Institution of Medical Cosmetology
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (2)
Subjects self-evaluating satisfaction
Patients rate their treatment satisfaction based on highly satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied.
Measured: 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.
Measured: 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start14 Dec 2016
- Primary completion7 May 2017
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal FillerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,552 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294562
- Sponsor's protocol ID
- PMCF-FE01
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Post-Market Clinical Follow-up of FACILLE®
- ClinicalTrials.gov ID
- NCT05294562
- Acronym / sponsor ID
- PMCF-FE01
- Conditions
- Dermal Filler, Hyaluronic Acid, Nasolabial Fold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,552 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Institution of Medical Cosmetology
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Subjects self-evaluating satisfaction
Time frame: 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection
Subjects self-evaluating effectiveness
Time frame: 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermal Filler and Hyaluronic Acid, run by SciVision Biotech Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events reported during the study period (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.