Nasolabial FoldsNCT05612958
Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds
A study testing DKM-410 and Juvederm ULTRA PLUS XC 1.0ml in people with Nasolabial Folds, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- DKM-410 and Juvederm ULTRA PLUS XC 1.0ml
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2021to 28 Jun 2022
- 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
- Age 19 years and older
- Wrinkle Severity Rating Scale (WSRS) 3 or 4
- Visually symmetrical bilateral nasolabial folds
- Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.
- Voluntarily decided to participate in the study and signed the informed consent form
- Willing to follow the protocol
Who cannot join
- History of undergoing a permanent or semi-permanent filler treatment on the face
- Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
- Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
- History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
- Hypersensitivity to Lidocaine or amide local anesthetic
- Positive for the intradermal response test
Show all 25Show fewer
- History of severe or plurality of allergies
- Having skin inflammation or infection in nasolabial folds
- History of keloid formation, hyperpigmentation, or hypertrophic scars on the face.
- History of streptococcal disease
- Uncontrolled epilepsy
- Porphyria
- Having or being currently suffering from autoimmune diseases
- History of immunodeficiency or immunosuppressive drugs
- History of herpetic eruption
- Having bleeding disorder or blood clotting disorder
- Having anticoagulant drugs or components within 72 hours from the application of medical advice
- Received antiplatelet drugs within 2 weeks from the application of medical advice
- Having high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical advice
- Received drugs that inhibit or decrease liver metabolism
- Clinically significant abnormalities on electrocardiogram
- Pregnant or breast-feeding or who planning to conceive
- Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness
- Other investigational products or procedures within 3 months from screening
- Not eligible due to other reasons at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds: Single Center, Prospective, Comparative, Randomized, Double Blinded (Subject, Evaluator), Matched Pairs Design, Non-inferiority, Pivotal Clinical Trial
The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.
- Conditions
- Nasolabial Folds
- Being tested
- DKM-410, Juvederm ULTRA PLUS XC 1.0ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKM-410Device
Injection up to 2.0ml
Juvederm ULTRA PLUS XC 1.0mlDevice
Injection up to 2.0ml
| Study group | Role | What they receive |
|---|---|---|
| DKM-410 | Experimental | Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline Receives: Device: DKM-410 |
| Juvederm ULTRA PLUS XC 1.0ml | Active comparator | Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline Receives: Device: Juvederm ULTRA PLUS XC 1.0ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.
Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline.
Measured: Baseline and Week 24
Secondary outcomes (6)
Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.
WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme.
Measured: Baseline and Weeks 8, 16 and 48.
Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.
The percentage of subjects whose WSRS score was lowered by 1 or more points.
Measured: Baseline and Weeks 8, 16, 24 and 48.
Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.
WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme.
Measured: Baseline and Weeks 8, 16, 24 and 48.
Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.
The percentage of subjects whose WSRS score was lowered by 1 or more points.
Measured: Baseline and Weeks 8, 16, 24 and 48.
Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.
Global Aesthetic Improvement Scale (GAIS) from -1 to 3, with grade -1 as worse, grade 0 as no change, grade 1 as improved, grade 2 as much improved, grade 3 as very much improved.
Measured: Baseline and Weeks 8, 16, 24 and 48.
Visual Analog Scale (VAS) after the treatment.
Visual Analog Scale (VAS) from 0mm to 100mm, with 0mm as no pain, 100mm as maximum pain.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start23 Mar 2021
- Primary completion14 Jan 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612958
- Sponsor's protocol ID
- DKM-410-MD-1
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds: Single Center, Prospective, Comparative, Randomized, Double Blinded (Subject, Evaluator), Matched Pairs Design, Non-inferiority, Pivotal Clinical Trial
- ClinicalTrials.gov ID
- NCT05612958
- Acronym / sponsor ID
- DKM-410-MD-1
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 10 Nov 2022 (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.
The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKM-410 | Experimental | Device: DKM-410Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline |
| Juvederm ULTRA PLUS XC 1.0ml | Active comparator | Device: Juvederm ULTRA PLUS XC 1.0mlParticipants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19 years and older
- Wrinkle Severity Rating Scale (WSRS) 3 or 4
- Visually symmetrical bilateral nasolabial folds
- Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.
- Voluntarily decided to participate in the study and signed the informed consent form
Key exclusion criteria (25 listed)
- History of undergoing a permanent or semi-permanent filler treatment on the face
- Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
- Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
- History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
- Hypersensitivity to Lidocaine or amide local anesthetic
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 |
|---|---|---|
| DKM-410Injection up to 2.0ml | Device | DKM-410 |
| Juvederm ULTRA PLUS XC 1.0mlInjection up to 2.0ml | Device | Juvederm ULTRA PLUS XC 1.0ml |
Primary outcome
Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24.
Time frame: Baseline and Week 24
Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline.
6 secondary outcomes
Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48.
Time frame: Baseline and Weeks 8, 16 and 48.
Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48.
Time frame: Baseline and Weeks 8, 16, 24 and 48.
Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48.
Time frame: Baseline and Weeks 8, 16, 24 and 48.
Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48.
Time frame: Baseline and Weeks 8, 16, 24 and 48.
Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48.
Time frame: Baseline and Weeks 8, 16, 24 and 48.
Visual Analog Scale (VAS) after the treatment.
Time frame: Baseline
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 14 Nov 2022.
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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 DKM-410 and Juvederm ULTRA PLUS XC 1.0ml in people with Nasolabial Folds, run by Dongkook Pharmaceutical Co., Ltd. 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 6 inclusion and 25 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 14 Nov 2022. 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?
Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24. (time frame: Baseline and Week 24). 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 14 Nov 2022.