Glabellar LinesPhase 3NCT07013279

Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines

A Phase 3 study testing DWP712 inj. and Botox® 100 Units in people with Glabellar Lines, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

To evaluate the efficacy and safety 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 inj. and Botox® 100 Units
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 324 participants
Where: 1 siteSouth Korea
Study dates: 15 Jul 2025to 31 Mar 2026
Phase: Phase 3

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 a facial wrinkle scale (FWS) score of ≥2 (moderate) for glabellar lines at maximum frown in the investigator's on-site assessment at screening

Who cannot join

Subjects with glabellar lines that cannot sufficiently be improved by physical attempts, e.g., glabellar lines not flattened by hand, in the judgment of the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

Chung-Ang University Hosptial
Seoul
Beom Joon Kim, MD, phD, +82262991525, beomjoon74@gmail.com

Other trials in South Korea

About this study

Official title: A Double-blind, Randomized, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP712 Inj. in Subjects With Moderate to Severe Glabellar Lines

To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines

Conditions: Glabellar Lines
Being tested: DWP712 inj., Botox® 100 Units

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DWP712 inj.Biological
Clostridium botulinum Toxin
Botox® 100 UnitsBiological
Clostridium botulinum Toxin

Study groups in NCT07013279
Study group	Role	What they receive
DWP712 inj.	Experimental	The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL. Receives: Biological: DWP712 inj.
Botox® 100 Units	Active comparator	The investigational product will be administered by a single intramuscular injection, and 4 U/0.1 mL of the IP will be injected into a total of 5 sites, totaling 20 U/0.5 mL. Receives: Biological: Botox® 100 Units

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of subjects with glabellar line improvement* rate at maximum frown based on the investigator's on-site assessment at 4 weeks after IP administration
Improvement means FWS grade of "0" or "1" with a ≥2-point improvement from baseline
Measured: At 4 weeks after IP administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202531 Mar 2026

First posted10 Jun 2025
Study start15 Jul 2025 (estimated)
Primary completion31 Dec 2025 (estimated)
Study completion31 Mar 2026 (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.
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: 324 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07013279
Sponsor's protocol ID: DW_DWP712301
Status last verified: Jun 2025
First submitted: 2 Jun 2025
Last updated: 10 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
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A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines

All Glabellar Lines trials