DWP450 for Treating Moderate to Severe Glabellar Lines

Phase 3

Completed

• Conditions: Moderate to Severe Glabellar Lines
• Interventions: Drug: DWP450; Drug: Botox®

• Registration Number: NCT06354127
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-12
• Primary Completion: 2020-11-24
• Study Completion: 2021-01-25
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

Inclusion Criteria

• Adult males or females aged 20-65 years old.
• Moderate to severe (grade 2-3) glabellar lines based on investigator's assessment of severity of glabellar lines at maximum frown.

Exclusion Criteria

• Having received any glabellar (including forehead) cosmetic procedures/surgeries, such as dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, or dermabrasion within 6 months prior to screening.
• Planning to receive any facial cosmetic procedures/surgeries, including but not limited dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, during the study period.
• Skin infection at injection site or systemic skin disease assessed with the potential to interfere with efficacy evaluation or safety evaluation of glabellar lines or forehead lines.
• Glabellar lines that cannot be fully flattened through surgery, by hand or by other methods.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP450	DWP450	-
Botox®	Botox®	-

Primary Outcome Measures

Name	Time	Method
Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown	Week 4	The difference between the two groups in response rate at Week 4 based on the investigator's on-site assessment of severity of glabellar lines (at maximum frown).

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China