An interventional study of ANIMERS Chiara LA and JUVÉDERM VOLUMA® in Dermal Filler, Hyaluronic Acid and Lidocaine, sponsored by SciVision Biotech Inc.. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by SciVision Biotech Inc. · Not applicable, Interventional, and Treatment
This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the active control group.
SciVision Biotech Inc. is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: ANIMERS Chiara LA
Device: JUVÉDERM VOLUMA®
20mg/SciVision Biotech Inc.
20mg/Allergan, Inc.
Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS)
The response rate is ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator at 6 months. Evaluators assess the midface volume deficit scale (MFVDS) on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.
Time frame: 6 months post-injection
Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months.
The digital image scoring system analyzes the volume change (ml). A higher score means more volume increased in the midface.
Time frame: Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Evaluators assess the midface volume deficit scale on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.
Time frame: Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
A Response rate of MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
The response rate is ≥ 1 Grade improvement on the assessment of the MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator after injection and 1, 3, 6, 12, 18, 24 months. Evaluators assess the midface volume deficit scale (MFVDS) on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'.
Time frame: Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months.
Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'.
Time frame: Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Time frame: Immediate,15, 30, 45 and 60 minutes post-injection
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.
Time frame: Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
Serious 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.
Time frame: Immediate, 1, 3, 6, 12, 18 and 24 months post-injection
Device failure reported before injection
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.
Time frame: Before injection
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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SciVision Biotech Inc.