NCT06354127CompletedPhase 3
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
Daewoong Pharmaceutical Co. LTD.1 site in 1 country473 target enrollmentStarted: August 12, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 473
- Locations
- 1
- Primary Endpoint
- Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
DWP450
Experimental
Intervention: DWP450 (Drug)
Botox®
Active Comparator
Intervention: Botox® (Drug)
Outcomes
Primary Outcomes
Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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