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

NCT06376838 | Completed DMC

• 1 other identifier: DLV-001-02
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  independent evaluators after 12 weeks of using the investigational medical device for clinical trials.

Secondary Outcomes (2)

• (1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale

  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 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.

Study Arms (2)

DLMR01

EXPERIMENTAL

* one side crow's feet * Single dose

Device: DLMR01

Rejuran

ACTIVE COMPARATOR

* one side crow's feet * Single Dose

Device: Rejuran

Interventions

DLMR01 DEVICE

Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject.

Also known as: Polycaprolactone filler

DLMR01

Rejuran DEVICE

Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject.

Also known as: Polynucleotide (PN)

Rejuran

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 19 years of age
• Subjects who voluntarily decided to participate in this clinical trial and provided written consent on the subject's informed consent form were included.
• Subjects who desired improvement in bilateral crow's feet wrinkles and had a Crow's Feet Grading Scale score of 2 or higher during both rest and maximum smiling were included. It was also required that the crow's feet wrinkles were visually symmetrical on both sides.
• Subjects who agreed not to undergo any procedures or treatments during the course of the clinical trial that could potentially affect the improvement of periorbital wrinkles, other than the interventions specified in the trial, were included.
• Subjects who were capable of understanding and following instructions and were available to participate throughout the entire pre-trial period were included.

You may not qualify if:

• Subjects who had taken anticoagulants (excluding low-dose aspirin, maximum 100mg/day, up to 300mg/day) or non-steroidal anti-inflammatory drugs within 2 weeks from the screening date were excluded.
• Subjects who had significant liver dysfunction or coagulation abnormalities, or those who needed to take anticoagulants (excluding low-dose aspirin, maximum 100mg/day, up to 300mg/day) during the clinical trial period were excluded.
• Subjects who had used topical agents (steroids, retinoids - limited to medications, excluding cosmetics) on their face within 1 month prior to the screening date or were planning to use them during the clinical trial period were excluded.
• Subjects who had undergone invasive laser procedures, deep chemical peels, or any other procedures or surgeries related to wrinkle improvement on their face within 6 months prior to the screening date were excluded.
• Subjects who had received wrinkle improvement treatments within 6 months prior to the screening date, such as collagen or hyaluronic acid fillers, polyalkylimide fillers, or any other treatments involving the use of injectable substances, were excluded.
• Subjects who had received wrinkle improvement treatments using calcium hydroxylapatite (CaHA) fillers within 12 months prior to the screening date were excluded.
• Subjects who had inserted permanent dermal fillers such as softform or silicone for facial augmentation in the facial area were excluded.
• Subjects who had facial scars that had not been treated for more than 12 months or had scars or marks in the areas where the investigational medical device would be applied were excluded.
• Subjects who have initiated or applied new wrinkle-preventing medications or cosmetics, including oral or topical formulations with wrinkle prevention effects, within the 3 months prior to their participation in the clinical trial, are excluded.
• Subjects who currently have skin disorders or wound infections in the facial area were excluded.
• Subjects with a history of anaphylaxis or severe complex allergies are excluded.
• Subjects with hypersensitivity or allergic reactions to the components of the product (Polycarprolactone) are excluded.
• Subjects with a history of hypertrophic scars or keloids are excluded.
• Subjects who have experienced adverse reactions to EMLA Cream in the past are excluded.
• Subjects who are drug or alcohol addicts are excluded.

Sponsors & Collaborators

• DEXLEVO: lead

Study Sites (1)

Chung-ang University Hospital

Seoul, Dongjak-gu, 06973, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 19, 2024
• Study Start: July 7, 2020
• Primary Completion: October 15, 2021
• Study Completion: May 4, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

KR (1)