MedTrace Logo

Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.

NCT05380154 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-05-24

No results posted yet for this study

Summary

This study is a phase 3 clinical trial of multi-center, random, blinded\*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.

Conditions

  • Glabellar Lines

Interventions

DRUG

Botulinum Toxin A type for injection (Botulax®)

Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects

DRUG

Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)

Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.

Sponsors & Collaborators

  • Sihuan Pharmaceutical Limited

    collaborator UNKNOWN

  • Hugel

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2018-01-22
Completion
2018-07-06

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT05380154 on ClinicalTrials.gov