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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04143854
Ethics application status
Date submitted
28/10/2019
Date registered
29/10/2019
Date last updated
19/03/2021

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) change of lateral canthal line at maximum smile
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2020
Sample size
Target
Accrual to date
Final
150
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04143854