DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

Benign Masseteric Hypertrophy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03369990
• Other study ID #: DW_DWP450008
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 26, 2017
• Last updated: December 11, 2017
• Start date: December 2017
• Est. completion date: October 2018

Study information

• Verified date: December 2017
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Masseteric Hypertrophy
• Hypertrophy

Intervention

Drug:
• Botulinum toxin type A
Botulinum toxin type A(DWP450)
• Placebos
Normal Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction amount of masseter muscle thickness	Reduction amount of masseter muscle thickness by Ultrasonography	At 12 weeks
Secondary	Reduction amount of masseter muscle thickness	Reduction amount of masseter muscle thickness by Ultrasonography	At 4,8,16 weeks
Secondary	Reduction amount of lower face volume	Reduction amount of lower face volume by 3D digital imaging	At 4, 8, 12, 16 weeks
Secondary	Overall satisfaction of subject	Overall satisfaction of subject by questionnaire	At 4, 8, 12, 16 weeks