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

To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Biological: DWP712; Biological: BOTOX®

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Beom Joon Kim, MD, Ph.D; Phone Number: +82262991525; Email: beomjoon74@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWP712; Patients 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.	Biological: DWP712; Clostridium botulinum Toxin
Active Comparator: Botox®; Patients 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.	Biological: BOTOX®; Clostridium botulinum Toxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Beom Joon Kim, MD, Ph.D, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWP712101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No