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

Phase 1

Completed

• Conditions: Glabellar Lines
• Interventions: Biological: DWP712; Biological: BOTOX®

• Registration Number: NCT06212960
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-28
• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-19
• Primary Completion: 2024-02-26
• Study Completion: 2024-03-21
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP712	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.
Botox®	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chung-Ang University Hosptial; 🇰🇷 Seoul, Korea, Republic of