ClinicalTrials.gg
Not yet recruitingNCT07783763Updated Aug 26, 2026

Study of DWP450 in Japanese Subjects With Glabellar Lines

A Phase 3 interventional study of DWP450 20 U and 0.9% Saline Solution 0.5 mL in Glabellar Lines, sponsored by Daewoong Pharmaceutical Co. LTD.. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Study to Evaluate the Efficacy and Safety of DWP450 in Japanese Subjects with Moderate to Severe Glabellar Lines

02

Conditions studied

  • Glabellar Lines
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female participants aged 18 to 64 years at the time of 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

Exclusion criteria

Exclusion Criteria:

  • 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 who are planning pregnancy during the study period or who are unwilling to use acceptable methods of (pregnant or breastfeeding women are also excluded.)
  • Subjects who have participated in another clinical trial and received or used an 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., , immunodeficiency, cardiovascular disease, pulmonary disease, renal disease, hepatic disease, alcohol or drug dependence, psychiatric disorders, etc.).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    DWP450

    Drug: DWP450 20 U

  • Placebo comparator
    Placebo

    Drug: 0.9% Saline Solution 0.5 mL

Interventions

  • Clostridium botulinum Toxin type A

  • Drug0.9% Saline Solution 0.5 mL

    Normal Saline 0.5 mL

06

What researchers measure

Primary outcomes

  1. The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site

    Time frame: Week 4

Secondary outcomes

  1. The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site

    Time frame: Week 8, 12

  2. 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

  3. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07783763
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jan 2027 (estimated)
Primary completion
May 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 26, 2026

Study contacts

Kim
Contact
hjkim037@daewoong.co.kr
+82-2-550-8381

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Prabotulinumtoxin A

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