DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

Phase 2

• Conditions: Benign Masseteric Hypertrophy
• Interventions: Drug: Placebos; Drug: Botulinum toxin type A

• Registration Number: NCT03369990
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-26
• Status Verified: 2017-12
• Study Start: 2017-12
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-12
• Last Update Posted: 2017-12-12
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Normal Saline
Botulinum toxin type A	Botulinum toxin type A	DWP450

Primary Outcome Measures

Name	Time	Method
Reduction amount of masseter muscle thickness	At 12 weeks	Reduction amount of masseter muscle thickness by Ultrasonography

Secondary Outcome Measures

Name	Time	Method
Reduction amount of masseter muscle thickness	At 4,8,16 weeks	Reduction amount of masseter muscle thickness by Ultrasonography
Reduction amount of lower face volume	At 4, 8, 12, 16 weeks	Reduction amount of lower face volume by 3D digital imaging
Overall satisfaction of subject	At 4, 8, 12, 16 weeks	Overall satisfaction of subject by questionnaire