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NCT04143815 Clinical Trial

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

Glabellar Frown Lines Clinical Trial

Official title:
PhaseII, 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 Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04143815
Other study ID # MT14-AU18GBL208
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 20, 2019
Est. completion date September 1, 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 study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo. This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female over 18 years of age - Bilaterally symmetrical moderate to severe GL at maximum frown 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 groups
• Placebo
Intramuscular injection

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 Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT02236312 - Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines Phase 2
Active, not recruiting NCT05565950 - AI-09 In Subjects With Glabellar Lines, GL-101 Phase 1/Phase 2
Completed NCT00430963 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines Phase 3
Recruiting NCT05083286 - Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines Early Phase 1
Completed NCT03687736 - Subject Satisfaction With AbobutulinumtoxinA Treatment Phase 4
Active, not recruiting NCT04281745 - Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® Phase 4
Active, not recruiting NCT05623410 - Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines Phase 3
Active, not recruiting NCT03440671 - The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines Phase 3
Completed NCT03736928 - Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines Phase 2
Completed NCT01808742 - Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device N/A
Completed NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines Phase 3
Completed NCT00430586 - Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines Phase 2
Completed NCT04281095 - A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines Phase 1/Phase 2
Active, not recruiting NCT05146999 - Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT02428608 - Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 Phase 2
Not yet recruiting NCT05305768 - Xeomin Treatment of Glabellar Lines Using OLD Versus COLD Early Phase 1
Completed NCT05364580 - The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines Phase 3
Completed NCT05320393 - Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines Phase 2
Completed NCT02677805 - Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II Phase 3
Not yet recruiting NCT05894109 - Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids N/A