NCT03369990UnknownPhase 2
A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects With Benign Masseteric Hypertrophy
Daewoong Pharmaceutical Co. LTD.0 sites98 target enrollmentStarted: December 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 98
- Primary Endpoint
- Reduction amount of masseter muscle thickness
Study Overview
Brief Summary
This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
- •Subject who had previously received botulinum toxin within 3 months 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
Placebo
Placebo Comparator
Normal Saline
Intervention: Placebos (Drug)
Botulinum toxin type A
Experimental
DWP450
Intervention: Botulinum toxin type A (Drug)
Outcomes
Primary Outcomes
Reduction amount of masseter muscle thickness
Time Frame: At 12 weeks
Reduction amount of masseter muscle thickness by Ultrasonography
Secondary Outcomes
- Overall satisfaction of subject(At 4, 8, 12, 16 weeks)
- Reduction amount of masseter muscle thickness(At 4,8,16 weeks)
- Reduction amount of lower face volume(At 4, 8, 12, 16 weeks)
Investigators
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