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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®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT10109 | Experimental | Clostridium botulinum toxin type A |
|
| Botox (registered trade mark) | Active Comparator | Clostridium botulinum toxin type A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT10109 | Biological | Single dose intramuscular injection MT10109 vs Botox® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Foley, Doctor | Austrailia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | MT10109 A Unit | Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL) |
| FG001 | MT10109 B Unit | Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL) |
| FG002 | MT10109 C Unit | Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL) |
| FG003 | Botox (Registered Trade Mark) | Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Set
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| ID | Title | Description |
|---|---|---|
| BG000 | MT10109 A Unit | Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL) |
| BG001 | MT10109 B Unit | Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Count of Participants | Participants | at Day 30 |
|
Until the End-of-Study Visit (Day 120)
This section focuses primarily on treatment-emergent adverse events (TEAEs), i.e., Adverse Events that started or worsened after the administration of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MT10109 A Unit | Single dose intramuscular injection of MT10109 (A Unit) at glabellar line (GL) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (15.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Ryu | Medytox Inc. | +82-2-6901-5890 | young.ryu@medytox.com |
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| BG002 | MT10109 C Unit | Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL) |
| BG003 | Botox (Registered Trade Mark) | Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | MT0109 B Unit | Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL) |
| OG002 | MT10109 C Unit | Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL) |
| OG003 | Botox (Registered Trade Mark) | Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL) |
|
|
| 0 |
| 31 |
| 7 |
| 31 |
| EG001 | MT10109 B Unit | Single dose intramuscular injection of MT10109 (B Unit) at glabellar line (GL) | 0 | 31 | 7 | 31 |
| EG002 | MT10109 C Unit | Single dose intramuscular injection of MT10109 (C Unit) at glabellar line (GL) | 1 | 27 | 10 | 27 |
| EG003 | Botox (Registered Trade Mark) | Single dose intramuscular injection of Botox (B Unit) at glabellar line (GL) | 1 | 32 | 10 | 32 |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) |
|
| NODULE | General disorders | MedDRA (15.0) |
|
| ACUTE TONSILLITIS | Infections and infestations | MedDRA (15.0) |
|
| BRONCHITIS | Infections and infestations | MedDRA (15.0) |
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| EYELID INFECTION | Infections and infestations | MedDRA (15.0) |
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| GASTROENTERITIS | Infections and infestations | MedDRA (15.0) |
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| HERPES ZOSTER | Infections and infestations | MedDRA (15.0) |
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| INFLUENZA | Infections and infestations | MedDRA (15.0) |
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| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (15.0) |
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| OTITIS MEDIA | Infections and infestations | MedDRA (15.0) |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (15.0) |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (15.0) |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (15.0) |
|
| VULVOVAGINAL CANDIDIASIS | Infections and infestations | MedDRA (15.0) |
|
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (15.0) |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (15.0) |
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| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA (15.0) |
|
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA (15.0) |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
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| TENOSYNOVITIS STENOSANS | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
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| HEAD DISCOMFORT | Nervous system disorders | MedDRA (15.0) |
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| HEADACHE | Nervous system disorders | MedDRA (15.0) |
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| MIGRAINE | Nervous system disorders | MedDRA (15.0) |
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| SYNCOPE | Nervous system disorders | MedDRA (15.0) |
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| TENSION HEADACHE | Nervous system disorders | MedDRA (15.0) |
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| DEPRESSION | Psychiatric disorders | MedDRA (15.0) |
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| RENAL COLIC | Renal and urinary disorders | MedDRA (15.0) |
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| BREAST MASS | Reproductive system and breast disorders | MedDRA (15.0) |
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| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA (15.0) |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (15.0) |
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| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (15.0) |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA (15.0) |
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| SEBACEOUS HYPERPLASIA | Skin and subcutaneous tissue disorders | MedDRA (15.0) |
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| TELANGIECTASIA | Skin and subcutaneous tissue disorders | MedDRA (15.0) |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (15.0) |
|
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