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Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

D

Daewoong Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Benign Masseteric Hypertrophy

Treatments

Drug: DWP450
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04294251
DW_DWP450301

Details and patient eligibility

About

This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
  3. Subject who had previously received botulinum toxin within 12 weeks 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 2 patient groups, including a placebo group

DWP450
Experimental group
Treatment:
Drug: DWP450
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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