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

Medy-Tox200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Glabellar Frown Lines

Interventions

MBA-P01 (Botulinum toxin A)DRUG

Intramuscular injection, dose varies by groups

PlaceboDRUG

Intramuscular injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maroubra MEdical Centre

Maroubra, New South Wales, Australia

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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