drugset
drugset / Trial / NCT04443244

Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

NCT04443244 ↗

Phase 2 Completed 80 enrolled Hugel
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Timeline

Start
2020-05-27
Primary completion
2020-11-18
Completion
2021-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 24 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 48 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 72 iu Intramuscular
Subject Botulinum toxin type A Protein / enzyme biologic 96 iu Intramuscular

Indications

masticatory muscles, hypertrophy of