NCT06376838

To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet

A Randomized, Subject and Evaluator Blinded, Split-face, Pivotal, Multi-injection Clinical Trial to Evaluate the Efficacy and Safety of DLMR01 in Crow's Feet.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: DEXLEVO · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 crow's 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 selection/exclusion 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.

Conditions

• Crow's Feet Lines

Interventions

Type	Name	Description
DEVICE	DLMR01	Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject.
DEVICE	Rejuran	Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject.

Timeline

• Start date: 2020-07-07
• Primary completion: 2021-10-15
• Completion: 2023-05-04
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: South Korea