Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines
Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines
1 other identifier
interventional
20
1 country
1
Brief Summary
To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2023
CompletedFirst Submitted
Initial submission to the registry
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2024
CompletedApril 4, 2024
January 1, 2024
3 months
January 8, 2024
April 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
At 4, 8, 12 week after the injection
Study Arms (2)
DWP712
EXPERIMENTALPatients were intramuscularly injected (IM) with a total of 20U of DWP712 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.
Botox®
ACTIVE COMPARATORPatients were intramuscularly injected (IM) with a total of 20U of BOTOX® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung-Ang University Hosptial
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beom Joon Kim, MD, Ph.D
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2024
First Posted
January 19, 2024
Study Start
November 28, 2023
Primary Completion
February 26, 2024
Study Completion
March 21, 2024
Last Updated
April 4, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share