Status:
COMPLETED
Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Benign Masseteric Hypertrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04294251
Start Date
March 4 2020
End Date
August 10 2021
Last Update
November 30 2022
Active Locations (1)
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1
Chung-ang University Hospital
Seoul, South Korea