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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04143854




Registration number
NCT04143854
Ethics application status
Date submitted
28/10/2019
Date registered
29/10/2019
Date last updated
29/10/2019

Titles & IDs
Public title
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
Scientific 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
Secondary ID [1] 0 0
MT14-AU18LCL209
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral Canthal Lines 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MBA-P01(Botulinum toxin A)
Treatment: Drugs - Placebo

Experimental: MBA-P01 24U - Experimental group; Dose: 24U

Experimental: MBA-P01 12U - Experimental group; Dose: 12U

Placebo Comparator: Placebo - Placebo group; normal saline


Treatment: Drugs: MBA-P01(Botulinum toxin A)
Intramuscular injection; Dose varies by group

Treatment: Drugs: Placebo
Intramuscular injection; normal saline

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Facial wrinkle scale(FWS) improvement of lateral canthal line at maximum smile - Proportion of subjects achieving at least a 2 grade improvement from baseline in FWS of LCL at maximum smile, as assessed by the investigator and subject
Timepoint [1] 0 0
4 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of facial nerve paralysis

- Any eyebrow or eyelied ptosis as determined by the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Maroubra Medical Centre - Maroubra
Recruitment postcode(s) [1] 0 0
2035 - Maroubra

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medy-Tox
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT04143854
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04143854