Glabellar Frown LinesPhase 2NCT04143815
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines
A Phase 2 study testing MBA-P01 (Botulinum toxin A) in people with Glabellar Frown Lines, run by Medy-Tox at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- MBA-P01 (Botulinum toxin A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 20 May 2019to 1 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of facial nerve paralysis
- Any eyebrow or eyelied ptosis as determined by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Glabellar Frown Lines
- Being tested
- MBA-P01 (Botulinum toxin A), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBA-P01 (Botulinum toxin A)Drug
Intramuscular injection, dose varies by groups
PlaceboDrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| MBA-P01 30U | Experimental | Experimental group, Dose: 30U Receives: Drug: MBA-P01 (Botulinum toxin A) |
| MBA-P01 20U | Experimental | Experimental group, Dose: 20U Receives: Drug: MBA-P01 (Botulinum toxin A) |
| MBA-P01 10U | Experimental | Experimental group, Dose: 10U Receives: Drug: MBA-P01 (Botulinum toxin A) |
| Placebo | Placebo comparator | Placebo group, Normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Wrinkle Scale(FWS) change
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start20 May 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143815
- Sponsor's protocol ID
- MT14-AU18GBL208
- Status last verified
- Mar 2021
- First submitted
- 28 Oct 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04143815
- Acronym / sponsor ID
- MT14-AU18GBL208
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBA-P01 30U | Experimental | Drug: MBA-P01 (Botulinum toxin A)Experimental group, Dose: 30U |
| MBA-P01 20U | Experimental | Drug: MBA-P01 (Botulinum toxin A)Experimental group, Dose: 20U |
| MBA-P01 10U | Experimental | Drug: MBA-P01 (Botulinum toxin A)Experimental group, Dose: 10U |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group, Normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- History of facial nerve paralysis
- Any eyebrow or eyelied ptosis as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBA-P01 (Botulinum toxin A)Intramuscular injection, dose varies by groups | Drug | MBA-P01 10U, MBA-P01 20U, MBA-P01 30U |
| PlaceboIntramuscular injection | Drug | Placebo |
Primary outcome
Facial Wrinkle Scale(FWS) change
Time frame: 4 weeks
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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Glabellar Frown Lines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBA-P01 (Botulinum toxin A) in people with Glabellar Frown Lines, run by Medy-Tox at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Wrinkle Scale(FWS) change (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.