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NCT Number: NCT07783763

Study of DWP450 in Japanese Subjects With Glabellar Lines

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

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

DWP450 20 U

Drug

Clostridium botulinum Toxin type A

0.9% Saline Solution 0.5 mL

Drug

Normal Saline 0.5 mL

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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