NCT04143854

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2020

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

October 28, 2019

Last Update Submit

March 18, 2021

Conditions

Lateral Canthal Lines

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

MBA-P01 24U

EXPERIMENTAL

Experimental group; Dose: 24U

Drug: MBA-P01(Botulinum toxin A)

MBA-P01 12U

EXPERIMENTAL

Experimental group; Dose: 12U

Drug: MBA-P01(Botulinum toxin A)

Placebo

PLACEBO COMPARATOR

Placebo group; normal saline

Drug: Placebo

Interventions

MBA-P01(Botulinum toxin A)DRUG

Intramuscular injection; Dose varies by group

MBA-P01 12UMBA-P01 24U
PlaceboDRUG

Intramuscular injection; normal saline

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of facial nerve paralysis
  • Any eyebrow or eyelied ptosis as determined by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maroubra Medical Centre

Maroubra, New South Wales, 2035, Australia

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 29, 2019

Study Start

May 21, 2019

Primary Completion

August 19, 2020

Study Completion

August 19, 2020

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

AU(1)