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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
218
Chung-ang University Hospital
Seoul, Dongjak-gu, South Korea
Crow's Feet Grading Scale by independent evaluators after 12 weeks of using
The improvement in wrinkles assessed using the Crow's Feet Grading Scale\[The scale grades wrinkles from 0(No wrinkles), 1(Very fine wrinkles),2(Fine wrinkles), 3(Moderate wrinkles), 4(Severe wrinkles)\] by independent evaluators after 12 weeks of using the investigational medical device for clinical trials \* Wrinkle improvement was evaluated before and after application of clinical study medical devices improved by at least 1 point on the Crow's Feet Grading Scale. It is defined as a case, and the wrinkle improvement rate is the number of wrinkles among the clinical study subjects that can be analyzed, and wrinkles improvement rate is defined as the percentage of wrinkles among analyzable clinical study subjects proportion of selected subjects.
Time frame: independent evaluators after 12 weeks of using the investigational medical device for clinical trials.
(1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale
(1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale\[The scale grades wrinkles from 0(No wrinkles), 1(Very fine wrinkles),2(Fine wrinkles), 3(Moderate wrinkles), 4(Severe wrinkles)\] by independent evaluators after 12 weeks of using the investigational medical device for clinical trials, specifically when smiling, was assessed. \* Wrinkle improvement was evaluated before and after application of clinical study medical devices improved by at least 1 point on the Crow's Feet Grading Scale. It is defined as a case, and the wrinkle improvement rate is the number of wrinkles among the clinical study subjects that can be analyzed, and wrinkles improvement rate is defined as the percentage of wrinkles among analyzable clinical study subjects proportion of selected subjects.
Time frame: 12 weeks of using the investigational medical device for clinical trials, specifically when smiling, was assessed.
(2) The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale by independent evaluators after 2 weeks and 4 weeks of using the medical device both during rest and when smiling was evaluated.
The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale\[The scale grades wrinkles from 0(No wrinkles), 1(Very fine wrinkles),2(Fine wrinkles), 3(Moderate wrinkles), 4(Severe wrinkles)\] by independent evaluators after 2 weeks and 4 weeks of using the investigational medical device for clinical trials, both during rest and when smiling was evaluated. \* Wrinkle improvement was evaluated before and after application of clinical study medical devices improved by at least 1 point on the Crow's Feet Grading Scale. It is defined as a case, and the wrinkle improvement rate is the number of wrinkles among the clinical study subjects that can be analyzed, and wrinkles improvement rate is defined as the percentage of wrinkles among analyzable clinical study subjects proportion of selected subjects.
Time frame: The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale by independent evaluators after 2 weeks and 4 weeks of using the investigational medical device for clinical trials, both during rest and when smiling was evaluated.
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