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

Nasolabial Fold Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03844529
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date March 1, 2019
Completion date August 31, 2020
View Details
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