Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376838
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2024-04-15
Brief Title:
To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crows Feet
Sponsor:
DEXLEVO
Organization:
DEXLEVO
Study Overview
Official Title:
A Randomized Subject and Evaluator Blinded Split-face Pivotal Multi-injection Clinical Trial to Evaluate the Efficacy and Safety of DLMR01 in Crows Feet
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
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:
dermal filler
Brief Summary:
This clinical study is a confirmatory clinical study to prove that the test device DLMR01 is non-inferior to the control device Rejuran in terms of temporary wrinkle improvement effect on crows feet and safety After applying DLMR01 a test device and Rejuran a control device respectively to wrinkles around the eyes randomization to compare and evaluate the temporary wrinkle improvement effect and safety of the two clinical study medical devices subject-evaluator blinding pair matching It was designed as a comparative clinical study
Detailed Description:
A total of 218 clinical study subjects participated in this clinical study and the clinical study subjects signed a written informed consent for this clinical study at the screening visit visit 1 and only if they satisfied various test results and selectionexclusion criteria Randomly prescribed and applied medical devices for clinical studys test devices control devices A total of 5 visits were scheduled for the subject and visit 1 screening visit was conducted within 14 days prior to the first application of the subjects clinical study medical device Subjects visited the clinical study institution at 2 weeks visit 3 4 weeks visit 4 and 12 weeks visit 5 after the final application of clinical study medical devices visit 2 and conducted observation and examination to conduct clinical study The efficacy and safety of the test medical device were confirmed
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