NCT04294251
Completed
Phase 3
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase Ⅲ Study to Evaluate the Efficacy and Safety of NABOTA® in Subjects With Benign Masseteric Hypertrophy
Daewoong Pharmaceutical Co. LTD.1 site in 1 country180 target enrollmentMarch 4, 2020
Overview
- Phase
- Phase 3
- Intervention
- DWP450
- Conditions
- Benign Masseteric Hypertrophy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change from baseline in masseter muscle thickness
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subject over 18 years of age and written informed consent is obtained.
- •Subject with Benign Masseter Hypertrophy.
- •Subject who has Bisymmetry of masseter at visual assessment.
- •Subjects who meets thickness of Masseter muscle by ultrasonography.
- •Subjects who can and will comply with the requirements of the protocol.
Exclusion Criteria
- •Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
- •Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
- •Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
- •Subject with known hypersensitivity to botulinum toxin.
- •Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
- •Subjects who are not eligible for this study at the discretion of the investigator.
Arms & Interventions
DWP450
Intervention: DWP450
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in masseter muscle thickness
Time Frame: 12 weeks
Change from baseline in masseter muscle thickness by Ultrasonography
Secondary Outcomes
- Change from baseline in lower face volume(24 weeks)
- Change from baseline in masseter muscle thickness(24 weeks)
- Overall satisfaction of subject: questionnaire(24 weeks)
Study Sites (1)
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