NCT03844529

Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds

Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds: a Prospective, Randomized, Active-controlled, Double Blinded, Multicenter Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds.

Detailed description

This is a prospective, randomized, active-controlled, double blinded (blinded evaluator and subject), multicenter clinical trial, which will be performed in Tri-Service General Hospital, Linkou ChangGung Memorial Hospital and National Taiwan University Hospital. These hospitals will recruit subjects in a competitive way. 240 subjects will be recruited in total, and each hospital will recruit 60\~120 subjects. The expected execution period is 2018/10\~2021/06. Subjects will be randomly assigned to receive the investigational device "Sumax FULLSGEN with Lidocaine" or controlled device "Sumax FACIALGAIN collagen Implant with Lidocaine" in 1:1 ratio. These devices will be processed to keep subjects and evaluators blinded.

Conditions

• Nasolabial Fold

Interventions

Type	Name	Description
DEVICE	Sunmax FULLSGEN with Lidocaine	Subject who voluntarily sign the informed consent form (day -14\~1) will be randomly assigned to investigational or control group and have intradermal allergy test. After the injection treatment by randomly choosing the device, every subject would have 6 follow-up visits.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-02-28
• Completion: 2020-08-31
• First posted: 2019-02-18
• Last updated: 2019-03-18

Locations

1 site across 1 country: Taiwan