DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

D

Daewoong Pharmaceutical

Status and phase

Unknown
Phase 2

Conditions

Benign Masseteric Hypertrophy

Treatments

Drug: Placebos
Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT03369990
DW_DWP450008

Details and patient eligibility

About

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

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

98 participants in 2 patient groups, including a placebo group

Botulinum toxin type A
Experimental group
Description:
DWP450
Treatment:
Drug: Botulinum toxin type A
Placebo
Placebo Comparator group
Description:
Normal Saline
Treatment:
Drug: Placebos

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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