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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects
Three hundred and twenty-four eligible subjects will be randomly assigned 3:1 to receive DWP-450 or placebo. Safety and efficacy will be assessed on Days 2, 7, 14, 30, 90, 120 and 150. The primary efficacy end point assesses the effectiveness of the DWP-450 against placebo on Day 30 in a superiority design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin, Type A | Experimental | Botulinum toxin, Type A |
|
| Placebo | Placebo Comparator | 0.9% sterile, unpreserved saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin, Type A | Biological | Botulinum toxin, Type A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | Secondary endpoint was the proportion of subjects classified as responders on Day 90. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 90 Day. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Avelar, MD | Evolus, iInc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clinical Testing Center of Beverly Hills | Beverly Hills | California | 90210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin, Type A | Botulinum toxin, Type A Botulinum toxin, Type A: Botulinum toxin, Type A |
| FG001 | Placebo | 0.9% sterile, unpreserved saline 0.9% sterile, unpreserved saline: Placebo Comparator Arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin, Type A | Botulinum toxin, Type A Botulinum toxin, Type A: Botulinum toxin, Type A |
| BG001 | Placebo | 0.9% sterile, unpreserved saline 0.9% sterile, unpreserved saline: Placebo Comparator Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Intent-to-treat | Posted | Number | 95% Confidence Interval | percentage of responders | Day 30 |
|
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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 | Botulinum toxin, Type A Botulinum toxin, Type A: Botulinum toxin, Type A |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rui L. Avelar, MD | Evolus, Inc | (805)689-8668 | rui@evolusinc.com |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C586826 | DWP450 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 0.9% sterile, unpreserved saline | Other | Placebo Comparator Arm |
|
| 90 Days |
| Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | Secondary endpoint was the proportion of subjects classified as responders on Day 120. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 120 Day GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Day 120 |
| Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | Secondary endpoint was the proportion of subjects classified as responders on Day 150. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 150 Day GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Day 150 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
0.9% sterile, unpreserved saline 0.9% sterile, unpreserved saline: Placebo Comparator Arm |
|
|
| Secondary | Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | Secondary endpoint was the proportion of subjects classified as responders on Day 90. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 90 Day. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Intent-to-treat | Posted | Number | 95% Confidence Interval | percentage of responders | 90 Days |
|
|
|
| Secondary | Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | Secondary endpoint was the proportion of subjects classified as responders on Day 120. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 120 Day GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Intent-to-treat | Posted | Number | 95% Confidence Interval | percentage of responders | Day 120 |
|
|
|
| Secondary | Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject | Secondary endpoint was the proportion of subjects classified as responders on Day 150. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 150 Day GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. | Intent-to-treat | Posted | Number | 95% Confidence Interval | percentage of responders | Day 150 |
|
|
|
| 4 |
| 246 |
| 66 |
| 246 |
| EG001 | Placebo | 0.9% sterile, unpreserved saline 0.9% sterile, unpreserved saline: Placebo Comparator Arm | 0 | 78 | 21 | 78 |
| Stress-induced cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | Non-systematic Assessment |
|
| Eyelid edema | Eye disorders | Non-systematic Assessment |
|
| Mild wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
|
| Mild dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | Non-systematic Assessment |
|
| Restless leg syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | Non-systematic Assessment |
|
| Diplopia | Eye disorders | Non-systematic Assessment |
|
| Eye pain | Eye disorders | Non-systematic Assessment |
|
| Keratitis | Eye disorders | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | Non-systematic Assessment |
|
| Eyebrow ptosis | Eye disorders | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Injection site bruising | General disorders | Non-systematic Assessment |
|
| Injection site pain | General disorders | Non-systematic Assessment |
|
| Injection site swelling | General disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Adnexa uteri mass | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | Non-systematic Assessment |
|
| Glucose urine present | Investigations | Non-systematic Assessment |
|
| Diabetes mellitis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Spinal decompression | Surgical and medical procedures | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | Non-systematic Assessment |
|
| Tooth abcess | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin sensitization | Skin and subcutaneous tissue disorders | Non-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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |