Crow's FeetNCT06021418
Efficacy and Safety of DKB-119 in Patients in Crow's Feet
A study testing DKB-119 in people with Crow's Feet, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Crow's Feet
- What is being tested?
- DKB-119
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2020to 31 Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are over 19 under 70 ages.
- Those who score 2 or more in the LCL severity evaluation.
- Those who have visually symmetrical crow's feet on both sides.
- Etc.
Who cannot join
- Pregnancy and lactating women.
- Etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Subject and Evaluator Blinded, Split-face, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of DKB-119 in Crow's Feet
To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet
Read the detailed description
A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical trial
- Conditions
- Crow's Feet
- Being tested
- DKB-119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKB-119Device
Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.
| Study group | Role | What they receive |
|---|---|---|
| DKB-119 | Experimental | Injecting to one side crow's feet Receives: Device: DKB-119 |
| Control | Active comparator | Injecting to one side crow's feet Receives: Device: DKB-119 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crow's feet
Difference in improvement rate (percentage)
Measured: 18 weeks
Secondary outcomes (3)
Crow's feet
Difference in improvement rate (percentage)
Measured: 8, 10 weeks
LCL(Lateral Canthal Line) Severity
Difference in improvement rate (percentage)
Measured: 8, 10, 18 weeks
GAIS(Global Aesthetic Improvement Scale)
GAIS 5 point scale (minimum -1 to maximum 3 points, The higher the score, the better the value)
Measured: 8, 10, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start2 Nov 2020
- Primary completion8 Sep 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's FeetStudies 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, Outcomes assessor
- Enrolment
- 100 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
- NCT06021418
- Sponsor's protocol ID
- DKB-119-MD-2
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Subject and Evaluator Blinded, Split-face, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of DKB-119 in Crow's Feet
- ClinicalTrials.gov ID
- NCT06021418
- Acronym / sponsor ID
- DKB-119-MD-2
- Conditions
- Crow's Feet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 1 Sep 2023 (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.
To prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet
Detailed description
A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKB-119 | Experimental | Device: DKB-119Injecting to one side crow's feet |
| Control | Active comparator | Device: DKB-119Injecting to one side crow's feet |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who are over 19 under 70 ages.
- Those who score 2 or more in the LCL severity evaluation.
- Those who have visually symmetrical crow's feet on both sides.
- Etc.
Key exclusion criteria (2 listed)
- Pregnancy and lactating women.
- Etc.
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 |
|---|---|---|
| DKB-119Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject. | Device | Control, DKB-119 |
Primary outcome
Crow's feet
Time frame: 18 weeks
Difference in improvement rate (percentage)
3 secondary outcomes
Crow's feet
Time frame: 8, 10 weeks
LCL(Lateral Canthal Line) Severity
Time frame: 8, 10, 18 weeks
GAIS(Global Aesthetic Improvement Scale)
Time frame: 8, 10, 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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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 DKB-119 in people with Crow's Feet, 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
Results are not available in the source record.
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 (time frame: 18 weeks). 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 13 Sep 2023.