Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler (NCT01918839) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler
South Korea46 participantsStarted 2014-02
Plain-language summary
This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI Plus as compared to Restylane-L® in correction of nasolabial fold.
Who can participate
Age range30 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female between the ages of 30-65, at the point of screening, wrinkles on both sides of treatment area (nasolabial fold) are in the 3rd or 4th level on the WSRS(Wrinkle Severity Rating Score)
* Surrounding soft tissue of wrinkles on both sides of nose and lips are sagging
* Wrinkles of both sides of nose and lips are visually symmetric
* Agrees to stop all other treatment of facial wrinkle improvement including dermatology treatment during clinical trial
* Able to understand and follow instructions and participate the entire period of the clinical trial
* Subject voluntarily agrees to participate in clinical trial and gives informed written consent
Exclusion Criteria:
* At the point of screening, intradermal test results show skin irritation to medical devices of clinical trial
* Within 2 weeks before the date of screening, subject has taken antithrombotic (with the exception of low dose aspirin 100mg, up to 300mg/day) or non-steroidal anti-inflammatory medication
* Case where subject has abnormal liver function or blood coagulation, has to take antithrombotic medication (with the exception of low dose aspirin 100mg, up to 300mg/day) during clinical trial
* Subject has used facial topical liniment (steroids, retinoids: excluding only medicines and cosmetics) within 4 weeks before date of screening or plans to continue using facial topical liniment during clinical trial
* Within 6 months before date of screening, subject has received anti-wrinkl…