Glabellar Frown Lines
Conditions
Brief 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®
Interventions
BIOLOGICALMT10109
Single dose intramuscular injection MT10109 vs Botox®
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | 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). |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MT10109 A Unit Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL) | 31 |
| MT10109 B Unit Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL) | 31 |
| MT10109 C Unit Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL) | 27 |
| Botox (Registered Trade Mark) Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL) | 32 |
| Total | 121 |
Baseline characteristics
| Characteristic | MT10109 A Unit | MT10109 B Unit | MT10109 C Unit | Botox (Registered Trade Mark) | Total |
|---|---|---|---|---|---|
| Age, Customized Age | 44.9 years STANDARD_DEVIATION 8.32 | 44.0 years STANDARD_DEVIATION 9.77 | 45.3 years STANDARD_DEVIATION 9.51 | 45.1 years STANDARD_DEVIATION 9.53 | 44.8 years STANDARD_DEVIATION 9.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 31 Participants | 27 Participants | 31 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Australia | 31 participants | 31 participants | 27 participants | 32 participants | 121 participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 24 Participants | 27 Participants | 107 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 31 | 7 / 31 | 10 / 27 | 10 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 1 / 27 | 1 / 32 |
Outcome results
Primary
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).
Time frame: at Day 30
Population: Full Analysis Set - comprised all randomized subjects who received at least one dose of study treatment and who had a glabellar lines severity rating at maximum frown at baseline and at least one post-baseline measurement.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MT10109 A Unit | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Responders at Day 30 at Max Frown | 18 Participants |
| MT10109 A Unit | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Non-responders at Day 30 at Max Frown | 12 Participants |
| MT0109 B Unit | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Non-responders at Day 30 at Max Frown | 8 Participants |
| MT0109 B Unit | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Responders at Day 30 at Max Frown | 18 Participants |
| MT10109 C Unit | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Responders at Day 30 at Max Frown | 22 Participants |
| MT10109 C Unit | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Non-responders at Day 30 at Max Frown | 3 Participants |
| Botox (Registered Trade Mark) | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Responders at Day 30 at Max Frown | 19 Participants |
| Botox (Registered Trade Mark) | Investigator's Rating of Glabellar Line Severity at Maximum Frown by Live Assessment. | Non-responders at Day 30 at Max Frown | 7 Participants |