Lateral Canthal LinesPhase 2NCT04143854
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
A Phase 2 study testing MBA-P01(Botulinum toxin A) in people with Lateral Canthal Lines, run by Medy-Tox at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Canthal 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
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- 21 May 2019to 19 Aug 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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: 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
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
- Conditions
- Lateral Canthal 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 group
PlaceboDrug
Intramuscular injection; normal saline
| Study group | Role | What they receive |
|---|---|---|
| MBA-P01 24U | Experimental | Experimental group; Dose: 24U Receives: Drug: MBA-P01(Botulinum toxin A) |
| MBA-P01 12U | Experimental | Experimental group; Dose: 12U 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 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
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 start21 May 2019
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal 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
- 150 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
- NCT04143854
- Sponsor's protocol ID
- MT14-AU18LCL209
- 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
- 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
- ClinicalTrials.gov ID
- NCT04143854
- Acronym / sponsor ID
- MT14-AU18LCL209
- Conditions
- Lateral Canthal Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBA-P01 24U | Experimental | Drug: MBA-P01(Botulinum toxin A)Experimental group; Dose: 24U |
| MBA-P01 12U | Experimental | Drug: MBA-P01(Botulinum toxin A)Experimental group; Dose: 12U |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group; normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
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 group | Drug | MBA-P01 12U, MBA-P01 24U |
| PlaceboIntramuscular injection; normal saline | Drug | Placebo |
Primary outcome
Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile
Time frame: 4 weeks
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
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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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 Lateral Canthal 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 of lateral canthal line at maximum smile (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.