DWP450 for Treating Moderate to Severe Glabellar Lines

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Glabellar Lines

Treatments: Drug: DWP450; Drug: Botox®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06354127

DW_DWP450009

Details and patient eligibility

About

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

Enrollment: 473 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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473 participants in 2 patient groups

DWP450

Experimental group

Treatment:

Drug: DWP450

Botox®

Active Comparator group

Treatment:

Drug: Botox®