Glabellar LinesPhase 3NCT07783763
Study of DWP450 in Japanese Subjects With Glabellar Lines
A Phase 3 study testing DWP450 20 U and 0.9% Saline Solution 0.5 mL in people with Glabellar Lines, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects with Moderate to Severe Glabellar Lines Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- DWP450 20 U and 0.9% Saline Solution 0.5 mL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants aged 18 to 64 years at the time of informed consent who have been Japanese nationals since birth
- At both the Screening Visit (Visit 1) and the Baseline Visit (Visit 2), a DW-FWS score of ≥2 (moderate) for glabellar lines at maximum frown, as assessed by the investigator at the study site
- Subjects who are able to understand and comply with the study procedures and visit schedule
- Subjects who have voluntarily provided written informed consent to participate in this clinical study
Who cannot join
- Subjects who are judged by the investigator to have glabellar lines that are not expected to improve sufficiently due to limitations, such as wrinkles at rest that do not disappear when manually stretched.
- Subjects who plan to undergo treatment with botulinum toxin products or any facial cosmetic procedures that may affect glabellar or forehead wrinkles (e.g. filler injections, photorejuvenation therapy, chemical peels, anti-wrinkle treatments, facelift, etc.) during the period from the Screening Visit (V1) to the End-of-Study Visit including the extension period.
- Female and male subjects of childbearing potential who are planning pregnancy during the study period or who are unwilling to use acceptable methods of contraception (pregnant or breastfeeding women are also excluded.)
- Subjects who have participated in another clinical trial and received or used an investigational drug or medical device within 1 month (4 weeks) prior to the Screening Visit (V1).
- Subjects who have a significant medical history that is considered by the investigator to make them unsuitable for participation in this clinical study (e.g., malignancy, immunodeficiency, cardiovascular disease, pulmonary disease, renal disease, hepatic disease, alcohol or drug dependence, psychiatric disorders, etc.).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects With Moderate to Severe Glabellar Lines
Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects with Moderate to Severe Glabellar Lines
- Conditions
- Glabellar Lines
- Being tested
- DWP450 20 U, 0.9% Saline Solution 0.5 mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP450 20 UDrug
Clostridium botulinum Toxin type A
0.9% Saline Solution 0.5 mLDrug
Normal Saline 0.5 mL
| Study group | Role | What they receive |
|---|---|---|
| DWP450 | Experimental | Not described Receives: Drug: DWP450 20 U |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% Saline Solution 0.5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site
Measured: Week 4
Secondary outcomes (3)
The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site
Measured: Week 8, 12
The responder rate for glabellar lines at rest, as assessed by investigators at the study site, among subjects with an investigator-assessed baseline at-rest DW-FWS score of 2 or 3
Measured: Week 4, 8
The responder rate for glabellar lines maximum frown, as assessed by independent evaluators based on photographs, among subjects with an independent evaluators-assessed baseline at maximum frown DW-FWS score of 2 or 3
Measured: Week 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783763
- Sponsor's protocol ID
- DW_DWP450302
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT07783763
- Acronym / sponsor ID
- DW_DWP450302
- Conditions
- Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
Study to Evaluate the Efficacy and Safety of DWP450 in Japanese 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 |
|---|---|---|
| DWP450 | Experimental | Drug: DWP450 20 U |
| Placebo | Placebo comparator | Drug: 0.9% Saline Solution 0.5 mL |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female participants aged 18 to 64 years at the time of informed consent who have been Japanese nationals since birth
- At both the Screening Visit (Visit 1) and the Baseline Visit (Visit 2), a DW-FWS score of ≥2 (moderate) for glabellar lines at maximum frown, as assessed by the investigator at the study site
- Subjects who are able to understand and comply with the study procedures and visit schedule
- Subjects who have voluntarily provided written informed consent to participate in this clinical study
Key exclusion criteria (5 listed)
- Subjects who are judged by the investigator to have glabellar lines that are not expected to improve sufficiently due to limitations, such as wrinkles at rest that do not disappear when manually stretched.
- Subjects who plan to undergo treatment with botulinum toxin products or any facial cosmetic procedures that may affect glabellar or forehead wrinkles (e.g. filler injections, photorejuvenation therapy, chemical peels, anti-wrinkle treatments, facelift, etc.) during the period from the Screening Visit (V1) to the End-of-Study Visit including the extension period.
- Female and male subjects of childbearing potential who are planning pregnancy during the study period or who are unwilling to use acceptable methods of contraception (pregnant or breastfeeding women are also excluded.)
- Subjects who have participated in another clinical trial and received or used an investigational drug or medical device within 1 month (4 weeks) prior to the Screening Visit (V1).
- Subjects who have a significant medical history that is considered by the investigator to make them unsuitable for participation in this clinical study (e.g., malignancy, immunodeficiency, cardiovascular disease, pulmonary disease, renal disease, hepatic disease, alcohol or drug dependence, psychiatric disorders, 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 |
|---|---|---|
| DWP450 20 UClostridium botulinum Toxin type A | Drug | DWP450 |
| 0.9% Saline Solution 0.5 mLNormal Saline 0.5 mL | Drug | Placebo |
Primary outcome
The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site
Time frame: Week 4
3 secondary outcomes
The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site
Time frame: Week 8, 12
The responder rate for glabellar lines at rest, as assessed by investigators at the study site, among subjects with an investigator-assessed baseline at-rest DW-FWS score of 2 or 3
Time frame: Week 4, 8
The responder rate for glabellar lines maximum frown, as assessed by independent evaluators based on photographs, among subjects with an independent evaluators-assessed baseline at maximum frown DW-FWS score of 2 or 3
Time frame: Week 4, 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP450 20 U and 0.9% Saline Solution 0.5 mL in people with Glabellar Lines, run by Daewoong Pharmaceutical Co. LTD..
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 5 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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim (+82-2-550-8381, hjkim037@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site (time frame: Week 4). 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 26 Aug 2026.