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

NCT06376838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

  • Crow's Feet Lines

Interventions

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.

Sponsors & Collaborators

  • DEXLEVO

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2021-10-15
Completion
2023-05-04

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06376838 on ClinicalTrials.gov