Status:
UNKNOWN
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Benign Masseteric Hypertrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
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 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03369990
Start Date
December 1 2017
End Date
October 1 2018
Last Update
December 12 2017
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