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

Medy-Tox150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Lateral Canthal Lines

Interventions

MBA-P01(Botulinum toxin A)DRUG

Intramuscular injection; Dose varies by group

PlaceboDRUG

Intramuscular injection; normal saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Maroubra Medical Centre

Maroubra, New South Wales, Australia

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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