Glabellar Frown LinesPhase 2NCT01485601
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines
A Phase 2 study testing MT10109 in people with Glabellar Frown Lines, run by Medy-Tox at 1 site in Australia.
Trial summary
The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX® Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- MT10109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Dec 2011to 17 Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
- Women of childbearing potential must have a negative serum pregnancy test at screening
Who cannot join
- Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
- Patients with an anaphylactic response history to botulinum toxin type A.
- Patients who have been administered botulinum toxin type A within the previous 6 months.
- Pregnant or lactating women.
- Participation in any research study involving drug administration within 90 days preceding enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®
The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®
- Conditions
- Glabellar Frown Lines
- Being tested
- MT10109
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT10109Biological
Single dose intramuscular injection MT10109 vs Botox®
| Study group | Role | What they receive |
|---|---|---|
| MT10109 | Experimental | Clostridium botulinum toxin type A Receives: Biological: MT10109 |
| Botox (registered trade mark) | Active comparator | Clostridium botulinum toxin type A Receives: Biological: MT10109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).
Measured: at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study start7 Dec 2011
- Primary completion30 Mar 2012
- Study completion17 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Foley, Doctor, Principal investigator, Austrailia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485601
- Sponsor's protocol ID
- MT-GPRT-GL01
- Status last verified
- Jul 2023
- First submitted
- 1 Dec 2011
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Multi-centre, Phase II, Optimal Dose-finding Study to Determine the Safety and Efficacy of MT10109 (Clostridium Botulinum Toxin Type A) in Subjects With Moderate to Severe Glabellar Lines in Comparison to BOTOX®
- ClinicalTrials.gov ID
- NCT01485601
- Acronym / sponsor ID
- MT-GPRT-GL01
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2011 (actual)
- Primary completion
- 30 Mar 2012 (actual)
- Study completion
- 17 Aug 2012 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find an optimal dose to determine the safety and tolerability of a single dose of MT10109(clostridium botulinum type A) administered by intramuscular injection in subjects with glabellar lines compared with the standard dose of BOTOX®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT10109 | Experimental | Biological: MT10109Clostridium botulinum toxin type A |
| Botox (registered trade mark) | Active comparator | Biological: MT10109Clostridium botulinum toxin type A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged between 18 and 75 years with glabellar facial lines of at least moderate severity at maximum frown by investigator's assessment.
- Women of childbearing potential must have a negative serum pregnancy test at screening
Key exclusion criteria (6 listed)
- Patients with an inability to substantially lessen glabellar lines by physically spreading them apart.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
- Patients with an anaphylactic response history to botulinum toxin type A.
- Patients who have been administered botulinum toxin type A within the previous 6 months.
- Pregnant or lactating women.
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 |
|---|---|---|
| MT10109Single dose intramuscular injection MT10109 vs Botox® | Biological | Botox (registered trade mark), MT10109 |
Primary outcome
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment.
Time frame: at Day 30
Subjects included in the analysis had to have a baseline glabellar line (GL) severity rating at maximum frown of moderate (2) or severe (3). The GL severity were measured using a 4-point scale (0: none; 1: mild; 2: moderate; 3: Severe). A responder was defined as having a severity rating of none (0) or mild (1) at the corresponding post-baseline visit. Percentages are based on the number of subjects with an assessment at the relevant visit (Day 30).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Glabellar Frown Lines
RecruitingPhase 4
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Wrinkle, Glabellar Frown Lines
Active, not recruitingEarly Phase 1
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
Wrinkles
Active, not recruitingPhase 1
Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines
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.
Peter Foley, Doctor principal investigator
Austrailia
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 MT10109 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 6 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 22 Feb 2024. 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. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. (time frame: at Day 30). 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 22 Feb 2024.