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This double-blind study has two parts for each subject (same population):
Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):
Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin type A | Experimental | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo |
|
| Placebo | Placebo Comparator | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders on the Severity of Lateral Canthal Lines "at Maximum Smile". | A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines | Participants were asked to assess their degree of satisfaction with the appearance of their lateral canthal lines using a 4-point scale with the grades Very satisfied, Satisfied, Dissatisfied, and Very dissatisfied. A participant is considered satisfied if he/she answers Very satisfied or Satisfied. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Type A | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. Part B was open-label, active treatment to all participants up to 1 year. (Therefore, "reason withdrawn" cannot be specified per group.) |
| FG001 | Placebo | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. Part B was open-label, active treatment to all participants up to 1 year. (Therefore, "reason withdrawn" cannot be specified per group.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A |
| |||||||||||||
| Part B |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Type A | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Number of Responders on the Severity of Lateral Canthal Lines "at Maximum Smile". | A positive response (responder) is defined as a grade of 0 or 1 (none or mild), as assessed by the investigator. | Posted | Count of Participants | Participants | Week 4 |
|
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Total Number at Risk in Arm "Botulinum Toxin Type A-Part B" is not consistent with the number in the Participant Flow for Part B since 11 subjects were ongoing in Part A at Day 85 when the Adverse Event (AE) summary for Part B begins; 326 were ongoing at Day 85 but only 315 received retreatment (which is when Part B started for an individual subject).
AEs were collected together for Part B and recorded AEs cannot be attributed to specific interventions for this Part (all received active).
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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 | Botulinum Toxin Type A - Part A | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo. Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo | Other |
|
| NOT COMPLETED |
|
During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo Botulinum Toxin Type A: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants Satisfied With the Appearance of Their Lateral Canthal Lines | Participants were asked to assess their degree of satisfaction with the appearance of their lateral canthal lines using a 4-point scale with the grades Very satisfied, Satisfied, Dissatisfied, and Very dissatisfied. A participant is considered satisfied if he/she answers Very satisfied or Satisfied. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| 0 |
| 252 |
| 5 |
| 252 |
| 0 |
| 252 |
| EG001 | Placebo - Part A | During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo. | 0 | 83 | 1 | 83 | 0 | 83 |
| EG002 | Botulinum Toxin Type A - Part B | Part B was open-label, active treatment to all participants up to 1 year. The retreatment, or first treatment if randomized to placebo, injection defines for each subject the start of Part B. | 0 | 326 | 11 | 326 | 0 | 326 |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Urinary bladder polyp | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Benign uterine neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
|
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Deafness transitory | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |