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

NCT04443244 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-11-16

No results posted yet for this study

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

Conditions

  • Benign Masseteric Hypertrophy

Interventions

DRUG

Botulinum Toxin Type A Injection (Botulax®) 24Units

Experimental: Botulax® 24Units

DRUG

Botulinum Toxin Type A Injection (Botulax®) 48Units

Experimental: Botulax® 48Units

DRUG

Botulinum Toxin Type A Injection (Botulax®) 72Units

Experimental: Botulax® 72Units

DRUG

Botulinum Toxin Type A Injection (Botulax®) 96Units

Experimental: Botulax® 96Units

OTHER

Normal Saline

Placebo Comparator: Normal Saline

Sponsors & Collaborators

  • Hugel

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04443244 on ClinicalTrials.gov