Back to resultsDWP450 Treatment in Subjects With Benign Masseteric Hypertrophy
Primary Purpose
Benign Masseteric Hypertrophy
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Benign Masseteric Hypertrophy
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botulinum toxin type A
Placebo
Arm Description
DWP450
Normal Saline
Outcomes
Primary Outcome Measures
Reduction amount of masseter muscle thickness
Reduction amount of masseter muscle thickness by Ultrasonography
Secondary Outcome Measures
Reduction amount of masseter muscle thickness
Reduction amount of masseter muscle thickness by Ultrasonography
Reduction amount of lower face volume
Reduction amount of lower face volume by 3D digital imaging
Overall satisfaction of subject
Overall satisfaction of subject by questionnaire
Full Information
NCT ID
NCT03369990
First Posted
November 26, 2017
Last Updated
December 11, 2017
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT03369990
Brief Title
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Masseteric Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin type A
Arm Type
Experimental
Arm Description
DWP450
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Botulinum toxin type A(DWP450)
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Normal Saline
Primary Outcome Measure Information:
Title
Reduction amount of masseter muscle thickness
Description
Reduction amount of masseter muscle thickness by Ultrasonography
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
Reduction amount of masseter muscle thickness
Description
Reduction amount of masseter muscle thickness by Ultrasonography
Time Frame
At 4,8,16 weeks
Title
Reduction amount of lower face volume
Description
Reduction amount of lower face volume by 3D digital imaging
Time Frame
At 4, 8, 12, 16 weeks
Title
Overall satisfaction of subject
Description
Overall satisfaction of subject by questionnaire
Time Frame
At 4, 8, 12, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
12. IPD Sharing Statement
Learn more about this trial
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy
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