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The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.
Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.
Subjects with moderate or severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment.
Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum neurotoxin, Type A | Experimental | DWP-450 (Botulinum purified neurotoxin, Type A) Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum purified neurotoxin, Type A | Biological | The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year | The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365. | 365 Days |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS) | GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS | 365 Days |
Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study):
Exclusion Criteria (A subject must not meet the following exclusion criteria in order to be eligible for enrollment in the stud)y:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Avelar, MD | Evolus, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATS Clinical Research | Santa Monica | California | 90404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26233808 | Derived | Nam HS, Park YG, Paik NJ, Oh BM, Chun MH, Yang HE, Kim DH, Yi Y, Seo HG, Kim KD, Chang MC, Ryu JH, Lee SU. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. J Neurol Sci. 2015 Oct 15;357(1-2):192-7. doi: 10.1016/j.jns.2015.07.028. Epub 2015 Jul 21. |
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Analysis will be of combined data for all subjects entered into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Neurotoxin, Type A | DWP-450 (Botulinum purified neurotoxin, Type A) Injection Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Neurotoxin, Type A | DWP-450 (Botulinum purified neurotoxin, Type A) Injection Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml. |
| 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 | The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year | The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365. | Posted | Count of Participants | Participants | 365 Days |
|
1 year
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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 Neurotoxin, Type A | DWP-450 (Botulinum purified neurotoxin, Type A) Injection Botulinum purified neurotoxin, Type A: The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device failure - failure of pacemaker/defibrillator | General disorders | 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 |
|---|---|
| C586826 | DWP450 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Open Label
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|
|
| work scheduling issues |
|
| various other reasons |
|
| Lost to Follow-up |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS) | GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS | 323 subjects had a GLS score at rest >0 (i.e., 1, 2 or 3) at baseline and therefore could potentially have had a ≥1 point improvement in GLS score at rest at a post-baseline visit; 32 were missing the EOS GLS assessment | Posted | Number | 95% Confidence Interval | percentage of responders | 365 Days |
|
|
|
| 0 |
| 352 |
| 7 |
| 352 |
| 141 |
| 352 |
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Malignant anorectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Ovarian Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Muscle tone disorder | Nervous system disorders | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Migraine with aura | Nervous system disorders | Non-systematic Assessment |
|
| Nerve compression | Nervous system disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Thoracic outlet syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Tooth infection | 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 |
|
| abscess limb | Infections and infestations | Non-systematic Assessment |
|
| cystitis | Infections and infestations | Non-systematic Assessment |
|
| ear infection | Infections and infestations | Non-systematic Assessment |
|
| herpes zoster | Infections and infestations | Non-systematic Assessment |
|
| laryngitis | Infections and infestations | Non-systematic Assessment |
|
| oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| oral herpes | Infections and infestations | Non-systematic Assessment |
|
| pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| pharyngitis streptococcal | Infections and infestations | Non-systematic Assessment |
|
| tinea faciei | Infections and infestations | Non-systematic Assessment |
|
| viral infection | Infections and infestations | Non-systematic Assessment |
|
| Influenza like illness | General disorders | Non-systematic Assessment |
|
| Injection site bruising | General disorders | Non-systematic Assessment |
|
| Injection site pain | General disorders | Non-systematic Assessment |
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| chest pain | General disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| injection site cyst | General disorders | Non-systematic Assessment |
|
| injection site laceration | General disorders | Non-systematic Assessment |
|
| injury associated with a device | General disorders | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | Non-systematic Assessment |
|
| Dry eye | Eye disorders | Non-systematic Assessment |
|
| Eyelid edema | Eye disorders | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | Non-systematic Assessment |
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| Presbyopia | Eye disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| osteoporosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pain in jaw | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| tenosynovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| incision site pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| lip injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| median nerve injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| post procedural swelling | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| wrist fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastro-esophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| large intestine polyp | Gastrointestinal disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| pancreatic cyst | Gastrointestinal disorders | Non-systematic Assessment |
|
| pancreatic pseudocyst | Gastrointestinal disorders | Non-systematic Assessment |
|
| toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Melanocytic nevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| rosacea | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| skin tightening | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| skin wrinkling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| ADHD | Psychiatric disorders | Non-systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hypercholesterolemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| hyperlipidemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| vulvovaginal swelling | Reproductive system and breast disorders | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| atrial tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| palpitations | Cardiac disorders | Non-systematic Assessment |
|
| hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| seasonal allergy | Immune system disorders | Non-systematic Assessment |
|
| ear congestion | Ear and labyrinth disorders | Non-systematic Assessment |
|
| glucose in urine | Investigations | Non-systematic Assessment |
|
| nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
|
| Endometrial Hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment |
|
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