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CompletedNCT04143854

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

Phase II, Randomized, Double-blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Lateral Canthal Lines

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Medy-Tox · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGMBA-P01(Botulinum toxin A)Intramuscular injection; Dose varies by group
DRUGPlaceboIntramuscular injection; normal saline

Timeline

Start date
2019-05-21
Primary completion
2020-08-19
Completion
2020-08-19
First posted
2019-10-29
Last updated
2021-03-19

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT04143854. Inclusion in this directory is not an endorsement.

Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines (NCT04143854) · Clinical Trials Directory