Evaluate the Safety & Efficacy of Botulax® in Subjects With Benign

Clinical Trial Description

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 ;

Study Design

See also
Status	Clinical Trial	Phase
Completed	`NCT04294251` - Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy	Phase 3
Recruiting	`NCT05964257` - To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy	Phase 3
Not yet recruiting	`NCT03369990` - DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT04294251 - Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Phase 3

Recruiting

NCT05964257 - To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy

Phase 3

Not yet recruiting

NCT03369990 - DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04443244
Study type	Interventional
Source	Hugel
Contact
Status	Completed
Phase	Phase 2
Start date	May 27, 2020
Completion date	July 16, 2021

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms