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NCT04143854 Clinical Trial

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

Lateral Canthal Lines Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04143854
Other study ID # MT14-AU18LCL209
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 21, 2019
Est. completion date August 19, 2020

Study information
Verified date March 2021
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 19, 2020
Est. primary completion date August 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Male or female aged 18 to 65 - Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile as assessed by both investigator and subject using FWS Exclusion Criteria: - History of facial nerve paralysis - Any eyebrow or eyelied ptosis as determined by the investigator

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MBA-P01(Botulinum toxin A)
Intramuscular injection; Dose varies by group
• Placebo
Intramuscular injection; normal saline

Locations
Country Name City State
Australia Maroubra Medical Centre Maroubra New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Medy-Tox

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile Proportion of subjects achieving at least a 2 grade decrease from baseline and a grade 0 or 1 in Facial Wrinkle Scale (0: none to 3: severe) of LCL at maximum smile, as assessed by the investigator and subject 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT02248844 - Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea
Completed NCT02195687 - BOTOX® in the Treatment of Crow's Feet Lines in China Phase 3
Completed NCT01951742 - Dose Finding Study In Subjects With Crow's Feet Phase 2
Completed NCT03721016 - MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL) Phase 3
Completed NCT03326856 - ET-01 in Subjects With Lateral Canthal Lines Phase 2
Completed NCT04157686 - MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL) Phase 3
Completed NCT03839693 - ET-01 in Subjects With Lateral Canthal Lines, LCL-208 Phase 2
Completed NCT03923634 - Princess® RICH for the Correction of Fine Lines N/A
Completed NCT03732833 - MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines Phase 3
Completed NCT00888914 - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines Phase 2
Completed NCT01358695 - Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet Phase 2
Completed NCT01124565 - Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults Phase 2
Completed NCT00247559 - Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet) Phase 2
Completed NCT01809964 - Clinical Trial to Evaluate ANT-1401 in Crow's Feet Phase 2
Completed NCT03911102 - Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines Phase 2
Completed NCT00968825 - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines Phase 2
Completed NCT04225260 - Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines Phase 3
Completed NCT01064518 - Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults Phase 2
Completed NCT00884234 - Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines Phase 2
Completed NCT04249687 - Treatment of Moderate to Severe Lateral Canthal Lines Phase 3