DWP450 for Treating Moderate to Severe Glabellar Lines

Moderate to Severe Glabellar Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06354127
• Other study ID #: DW_DWP450009
• Status: Completed
• Phase: Phase 3
• Start date: August 12, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: April 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: January 25, 2021
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Glabellar Lines

Intervention

Drug:
• DWP450
The test drug or control drug is injected on the day of administration.
• Botox®
The test drug or control drug is injected on the day of administration.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown	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).	Week 4