Glabellar LinesPhase 1NCT06212960
Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines
A Phase 1 study testing DWP712 and BOTOX® in people with Glabellar Lines, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- DWP712 and BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Nov 2023to 21 Mar 2024
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines
To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.
- Conditions
- Glabellar Lines
- Being tested
- DWP712, BOTOX®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP712Biological
Clostridium botulinum Toxin
BOTOX®Biological
Clostridium botulinum Toxin
| Study group | Role | What they receive |
|---|---|---|
| DWP712 | Experimental | Patients were intramuscularly injected (IM) with a total of 20U of DWP712 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Receives: Biological: DWP712 |
| Botox® | Active comparator | Patients were intramuscularly injected (IM) with a total of 20U of BOTOX® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Receives: Biological: BOTOX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
Measured: At 4, 8, 12 week after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start28 Nov 2023
- Primary completion26 Feb 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon Kim, MD, Ph.D, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212960
- Sponsor's protocol ID
- DW_DWP712101
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06212960
- Acronym / sponsor ID
- DW_DWP712101
- Conditions
- Glabellar Lines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 19 Jan 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.
To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWP712 | Experimental | Biological: DWP712Patients were intramuscularly injected (IM) with a total of 20U of DWP712 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. |
| Botox® | Active comparator | Biological: BOTOX®Patients were intramuscularly injected (IM) with a total of 20U of BOTOX® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening
Key exclusion criteria (1 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 |
|---|---|---|
| DWP712Clostridium botulinum Toxin | Biological | DWP712 |
| BOTOX®Clostridium botulinum Toxin | Biological | Botox® |
Primary outcome
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
Time frame: At 4, 8, 12 week after the injection
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 4 Apr 2024.
- 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.
Beom Joon Kim, MD, Ph.D principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWP712 and BOTOX® in people with Glabellar Lines, run by Daewoong 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 1 inclusion and 1 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 4 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0 (time frame: At 4, 8, 12 week after the injection). 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 4 Apr 2024.