Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224649
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2019-09-05
Brief Title:
To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane Lidocaine in Temporary Correction of Nasolabial Folds
Sponsor:
Huons Co Ltd
Organization:
Huons Co Ltd
Study Overview
Official Title:
A Single Center Randomized Subject Evaluator-blind Matched Pairs Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane Lidocaine in Temporary Correction of Nasolabial Folds
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigational Device HARA Hyaluronic Acid Filler
Title A Single center Randomized Subject Evaluator-blind Matched pairs Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane Lidocaine in temporary Correction of Nasolabial folds
Sites and investigators Chung-ang University HospitalSeoul Beom-Joon Kim MD PhD
Objective To compare the non-inferiority of HARA with Restylane Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
Title A Single center Randomized Subject Evaluator-blind Matched pairs Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane Lidocaine in temporary Correction of Nasolabial folds
Sites and investigators Chung-ang University HospitalSeoul Beom-Joon Kim MD PhD
Objective To compare the non-inferiority of HARA with Restylane Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None