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DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

NCT ID: NCT03369990

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2018-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Benign Masseteric Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Botulinum toxin type A

DWP450

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Botulinum toxin type A(DWP450)

Placebo

Normal Saline

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Normal Saline

Interventions

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Botulinum toxin type A

Botulinum toxin type A(DWP450)

Intervention Type DRUG

Placebos

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subject over 18 years of age and written informed consent is obtained.
2. Subject with Benign Masseter Hypertrophy
3. Subject who has Bisymmetry of masseter at visual assessment.
4. Subjects who meets thickness of Masseter muscle by ultrasonography.
5. Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria

1. Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
2. Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
3. Subject who had previously received botulinum toxin within 3 months prior to the study entry
4. Subject with known hypersensitivity to botulinum toxin
5. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
6. Subjects who are not eligible for this study at the discretion of the investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW_DWP450008

Identifier Type: -

Identifier Source: org_study_id