Study of DWP450 in Japanese Subjects With Glabellar Lines

NCT07783763 — Phase 3, Not yet recruiting, 120 participants, Daewoong Pharmaceutical Co. LTD.

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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

Registry	NCT07783763
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	120 (Estimated)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Glabellar Lines
Interventions	DWP450 20 U, 0.9% Saline Solution 0.5 mL (Drug)
Dates	start 2027-01-01 (estimated), primary completion 2028-05-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-08-25, last updated 2026-08-26

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
DWP450	Experimental	Drug: DWP450 20 U
Placebo	Placebo comparator	Drug: 0.9% Saline Solution 0.5 mL

DWP450 20 U (Drug): Clostridium botulinum Toxin type A
0.9% Saline Solution 0.5 mL (Drug): Normal Saline 0.5 mL

+Outcome measures

Primary outcomes

The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site [Week 4]

Secondary outcomes

The responder rate for glabellar lines at maximum frown, as assessed by investigators at the study site [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 [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 [Week 4, 8]

+Eligibility

Sex: All, ages: 18 Years to 64 Years

Inclusion Criteria:

* 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

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 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.).