Crow's Feet Linesdermal fillerNCT06376838
To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet
A study testing DLMR01 and Rejuran in people with Crow's Feet Lines, run by DEXLEVO at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Crow's Feet Lines
- What is being tested?
- DLMR01 and Rejuran
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2020to 4 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- [Exclusion Criteria]
Show all 28Show fewer
- 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.
- Subjects with severe immunodeficiency disorders, including AIDS, or those receiving immunosuppressive therapy are excluded.
- Subjects with a history of recurrent streptococcal infections are excluded.
- Subjects with clinically significant disorders affecting the cardiovascular, digestive, respiratory, endocrine, or central nervous systems, or those with significant psychiatric disorders that have had or may have a significant impact on the clinical trial, are excluded.
- Subjects who have participated in another clinical trial within 1 month prior to the screening date are excluded.
- Female clinical trial subjects who are of childbearing potential and do not agree to use medically acceptable methods of contraception during the clinical trial period are excluded.
- Pregnant women, lactating women, and those planning to become pregnant are excluded.
- Subjects who are deemed by the investigational device to be inappropriate for participation in this clinical trial based on their own judgment are excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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
- Being tested
- DLMR01, Rejuran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLMR01Device
Also called Polycaprolactone filler
Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject.
RejuranDevice
Also called Polynucleotide (PN)
Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject.
| Study group | Role | What they receive |
|---|---|---|
| DLMR01 | Experimental | * one side crow's feet
* Single dose Receives: Device: DLMR01 |
| Rejuran | Active comparator | * one side crow's feet
* Single Dose Receives: Device: Rejuran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
(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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start7 Jul 2020
- Primary completion15 Oct 2021
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's Feet LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- DEXLEVO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376838
- Sponsor's protocol ID
- DLV-001-02
- Acronym
- dermal filler
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06376838
- Acronym / sponsor ID
- dermal filler / DLV-001-02
- Conditions
- Crow's Feet Lines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- DEXLEVOIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLMR01 | Experimental | Device: DLMR01* one side crow's feet * Single dose |
| Rejuran | Active comparator | Device: Rejuran* one side crow's feet * Single Dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLMR01Also: Polycaprolactone fillerExperimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject. | Device | DLMR01 |
| RejuranAlso: Polynucleotide (PN)Experimental and Acitve Comparator are applied 1 time to each of crow's feet on both sides of the subject. | Device | Rejuran |
Primary outcome
Crow's Feet Grading Scale by independent evaluators after 12 weeks of using
Time frame: independent evaluators after 12 weeks of using the investigational medical device for clinical trials.
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.
2 secondary outcomes
(1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLMR01 and Rejuran in people with Crow's Feet Lines, run by DEXLEVO at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crow's Feet Grading Scale by independent evaluators after 12 weeks of using (time frame: independent evaluators after 12 weeks of using the investigational medical device for clinical trials.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.