Dermal Filler, Hyaluronic Acid, Nasolabial Fold
Conditions
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.
Interventions
None listed
Sponsors
SciVision Biotech Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events reported during the study period | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjects self-evaluating satisfaction | 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. |
| Subjects self-evaluating effectiveness | 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection | Patients rate their effectiveness based on effective and ineffective. |
Outcome results
None listed