Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines

NCT04143854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-03-19

No results posted yet for this study

Summary

This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01

Conditions

  • Lateral Canthal Lines

Interventions

DRUG

MBA-P01(Botulinum toxin A)

Intramuscular injection; Dose varies by group

DRUG

Placebo

Intramuscular injection; normal saline

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2020-08-19
Completion
2020-08-19

Countries

  • Australia

Study Locations

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Entities

Drugs

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 NCT04143854 on ClinicalTrials.gov