DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

NCT03369990 | Unknown Phase 2

• 1 other identifier: DW_DWP450008
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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

Conditions

Benign Masseteric Hypertrophy

Outcome Measures

Primary Outcomes (1)

• Reduction amount of masseter muscle thickness

  Reduction amount of masseter muscle thickness by Ultrasonography

  At 12 weeks

Secondary Outcomes (3)

• Reduction amount of masseter muscle thickness

  At 4,8,16 weeks

• Reduction amount of lower face volume

  At 4, 8, 12, 16 weeks

• Overall satisfaction of subject

  At 4, 8, 12, 16 weeks

Study Arms (2)

Botulinum toxin type A

EXPERIMENTAL

DWP450

Drug: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

Normal Saline

Drug: Placebos

Interventions

Botulinum toxin type A DRUG

Botulinum toxin type A(DWP450)

Botulinum toxin type A

Placebos DRUG

Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 12, 2017
• Study Start: December 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 12, 2017

Record last verified: 2017-12