Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04143815




Registration number
NCT04143815
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 Glabellar Lines
Scientific title
PhaseII, 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 Glabellar Lines
Secondary ID [1] 0 0
MT14-AU18GBL208
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glabellar Frown 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 30U - Experimental group, Dose: 30U

Experimental: MBA-P01 20U - Experimental group, Dose: 20U

Experimental: MBA-P01 10U - Experimental group, Dose: 10U

Placebo comparator: Placebo - Placebo group, Normal saline


Treatment: Drugs: MBA-P01 (Botulinum toxin A)
Intramuscular injection, dose varies by groups

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

Outcomes
Primary outcome [1] 0 0
Facial Wrinkle Scale(FWS) change
Timepoint [1] 0 0
4 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
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
20/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
Accrual to date
Final
200
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 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.
Trial website
https://clinicaltrials.gov/study/NCT04143815
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/study/NCT04143815