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Trial record 4 of 737 for:    Botulinum Toxins, Type A

Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 (EV-006)

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ClinicalTrials.gov Identifier: NCT02428608
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : February 5, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Evolus, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glabellar Frown Lines
Intervention Biological: DWP-450 (Botulinum purified neurotoxin, Type A)
Enrollment 570
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin, Tyoe A
Hide Arm/Group Description

DWP-450 (Botulinum toxin, Type A)

DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A

Period Title: Overall Study
Started 570
Completed 487
Not Completed 83
Reason Not Completed
Pregnancy             2
Lost to Follow-up             37
Withdrawal by Subject             2
scheduling conflicts             15
moved away             10
Death             1
various             16
Arm/Group Title Botulinum Toxin, Type A
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DWP-450 (Botulinum toxin, Type A)

DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A

Overall Number of Baseline Participants 570
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants
<=18 years
0
   0.0%
Between 18 and 65 years
519
  91.1%
>=65 years
51
   8.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants
Female
510
  89.5%
Male
60
  10.5%
1.Primary Outcome
Title The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
Hide Description 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.
Time Frame 365 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Toxin, Tyoe A
Hide Arm/Group Description:

DWP-450 (Botulinum toxin, Type A)

DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A

Overall Number of Participants Analyzed 570
Measure Type: Count of Participants
Unit of Measure: Participants
235
  41.2%
2.Other Pre-specified Outcome
Title Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown
Hide Description Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment
Time Frame 365 days
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Hide Analysis Population Description
By Investigator assessment, 500 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; 64 subjects were missing the EOS GLS assessment
Arm/Group Title Botulinum Toxin, Type A
Hide Arm/Group Description:

DWP-450 (Botulinum toxin, Type A)

DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A

Overall Number of Participants Analyzed 500
Measure Type: Count of Participants
Unit of Measure: Participants
355
  71.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin, Type A
Hide Arm/Group Description

DWP-450 (Botulinum toxin, Type A)

DWP-450 (Botulinum purified neurotoxin, Type A): Botulinum toxin, Type A

All-Cause Mortality
Botulinum Toxin, Type A
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin, Type A
Affected / at Risk (%) # Events
Total   7/570 (1.23%)    
Gastrointestinal disorders   
Small intestinal obstruction *  1/570 (0.18%)  1
Colitis *  1/570 (0.18%)  1
Injury, poisoning and procedural complications   
Overdose *  1/570 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer *  1/570 (0.18%)  1
Uterine leiomyoma *  1/570 (0.18%)  1
Squamous cell carcinoma *  1/570 (0.18%)  1
Nervous system disorders   
Carotid artery stenosis *  1/570 (0.18%)  1
Psychiatric disorders   
Anxiety *  1/570 (0.18%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botulinum Toxin, Type A
Affected / at Risk (%) # Events
Total   228/570 (40.00%)    
Blood and lymphatic system disorders   
Anemia *  2/570 (0.35%)  2
Lymphadenopathy *  1/570 (0.18%)  1
Thrombocytosis *  2/570 (0.35%)  2
Cardiac disorders   
Bradycardia *  2/570 (0.35%)  2
Bundle branch block right *  3/570 (0.53%)  3
Sinus arrhythmia *  2/570 (0.35%)  2
Sinus bradycardia *  2/570 (0.35%)  2
atrioventricular block first degree *  1/570 (0.18%)  1
myocardial infarction *  1/570 (0.18%)  1
supraventricular extrasystoles *  1/570 (0.18%)  1
tachycardia *  1/570 (0.18%)  1
Ear and labyrinth disorders   
Cerumen impaction *  1/570 (0.18%)  1
Tinnitus *  2/570 (0.35%)  2
Vertigo *  3/570 (0.53%)  3
Endocrine disorders   
hypothyroidism *  2/570 (0.35%)  2
Eye disorders   
Blepharospasm *  2/570 (0.35%)  2
Brow ptosis *  3/570 (0.53%)  3
Eyelid ptosis *  7/570 (1.23%)  8
Vision blurred *  2/570 (0.35%)  2
blepharitis *  1/570 (0.18%)  1
cataract *  1/570 (0.18%)  1
chalazion *  1/570 (0.18%)  1
dry eye   1/570 (0.18%)  1
eye swelling *  1/570 (0.18%)  1
eyelid oedema *  1/570 (0.18%)  1
eyelid sensory disorder *  1/570 (0.18%)  1
ocular rosacea *  1/570 (0.18%)  1
Gastrointestinal disorders   
Colitis *  1/570 (0.18%)  1
Dysphagia *  2/570 (0.35%)  2
Gastroesophageal reflux disease *  2/570 (0.35%)  2
Toothache *  3/570 (0.53%)  3
abdominal discomfort *  1/570 (0.18%)  1
abdominal pain *  1/570 (0.18%)  1
abdominal pain upper *  1/570 (0.18%)  1
diverticulum *  1/570 (0.18%)  1
dyspepsia *  1/570 (0.18%)  1
gastritis *  1/570 (0.18%)  1
large intestine polyp *  1/570 (0.18%)  1
nausea *  1/570 (0.18%)  1
paraesthesia oral *  1/570 (0.18%)  1
salivary gland disorder *  1/570 (0.18%)  1
tooth disorder *  1/570 (0.18%)  1
General disorders   
Injection site bruising *  2/570 (0.35%)  3
Injection site pain *  3/570 (0.53%)  3
Injection site swelling *  3/570 (0.53%)  3
Pyrexia *  3/570 (0.53%)  5
fatigue *  1/570 (0.18%)  1
injection site pruritus *  1/570 (0.18%)  1
injection site reaction *  1/570 (0.18%)  1
local swelling *  1/570 (0.18%)  1
tenderness *  1/570 (0.18%)  1
Hepatobiliary disorders   
hepatic cyst *  1/570 (0.18%)  1
Immune system disorders   
Hypersensitivity *  3/570 (0.53%)  3
Seasonal allergy *  2/570 (0.35%)  2
Infections and infestations   
Bronchitis *  7/570 (1.23%)  7
Herpes zoster *  3/570 (0.53%)  3
Hordeolum *  2/570 (0.35%)  2
Influenza *  5/570 (0.88%)  5
Nasopharyngitis *  13/570 (2.28%)  16
Pharyngitis streptococcal *  2/570 (0.35%)  2
Sinusitis *  14/570 (2.46%)  15
Tooth abscess *  2/570 (0.35%)  2
Upper respiratory tract infection *  16/570 (2.81%)  19
Urinary tract infection *  10/570 (1.75%)  10
cellulitis *  1/570 (0.18%)  1
conjunctivitis *  1/570 (0.18%)  1
cystitis *  1/570 (0.18%)  1
diverticulitis *  1/570 (0.18%)  1
ear infection *  1/570 (0.18%)  1
eye infection *  1/570 (0.18%)  1
folliculitis *  1/570 (0.18%)  1
gastroenteritis *  1/570 (0.18%)  1
genital herpes *  1/570 (0.18%)  1
Helicobacter gastritis *  1/570 (0.18%)  1
Herpes simplex *  1/570 (0.18%)  1
oral herpes *  1/570 (0.18%)  1
otitis media *  1/570 (0.18%)  1
pharyngitis *  1/570 (0.18%)  1
tooth infection *  1/570 (0.18%)  1
vaginitis gardnerella *  1/570 (0.18%)  1
viral infection *  1/570 (0.18%)  1
Injury, poisoning and procedural complications   
Contusion *  9/570 (1.58%)  10
Foot fracture *  4/570 (0.70%)  4
Hand fracture *  2/570 (0.35%)  2
Ligament sprain *  2/570 (0.35%)  2
Meniscus injury *  2/570 (0.35%)  2
Procedural pain *  4/570 (0.70%)  4
Road traffic accident *  2/570 (0.35%)  2
Arthropod bite *  1/570 (0.18%)  1
Concussion *  1/570 (0.18%)  1
Excoriation *  1/570 (0.18%)  1
Eye laser scar *  1/570 (0.18%)  1
Facial bones fracture *  1/570 (0.18%)  1
Fall *  1/570 (0.18%)  1
Fibula fracture *  1/570 (0.18%)  1
Laceration *  1/570 (0.18%)  1
Limb injury *  1/570 (0.18%)  1
Lower limb fracture *  1/570 (0.18%)  1
Muscle strain *  1/570 (0.18%)  1
Post procedural discomfort *  1/570 (0.18%)  1
Rib fracture *  1/570 (0.18%)  1
Sunburn *  1/570 (0.18%)  1
Tendon injury *  1/570 (0.18%)  1
Tibia fracture *  1/570 (0.18%)  1
Wrist fracture *  1/570 (0.18%)  1
Investigations   
Blood creatinine increased *  2/570 (0.35%)  2
electrocardiogram QT prolonged *  1/570 (0.18%)  1
electrocardiogram T wave abnormal *  1/570 (0.18%)  1
electrocardiogram abnormal *  1/570 (0.18%)  1
intraocular pressure test *  1/570 (0.18%)  1
QRS axis abnormal *  1/570 (0.18%)  1
Metabolism and nutrition disorders   
hypercholesterolaemia *  1/570 (0.18%)  1
hyperkalaemia *  1/570 (0.18%)  1
vitamin D deficiency *  1/570 (0.18%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia *  3/570 (0.53%)  3
Back pain *  4/570 (0.70%)  4
Intervertebral disc protrusion *  2/570 (0.35%)  2
Muscle spasms *  2/570 (0.35%)  4
Neck pain *  4/570 (0.70%)  4
Pain in extremity *  6/570 (1.05%)  6
Plantar fasciitis *  2/570 (0.35%)  2
Trigger finger *  1/570 (0.18%)  2
arthritis *  1/570 (0.18%)  1
fibromyalgia *  1/570 (0.18%)  1
fracture pain *  1/570 (0.18%)  1
mobility decreased *  1/570 (0.18%)  1
osteoarthritis *  1/570 (0.18%)  1
pain in jaw *  1/570 (0.18%)  1
spinal osteoarthritis *  1/570 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Thyroid neoplasm *  2/570 (0.35%)  2
Uterine leiomyoma *  1/570 (0.18%)  1
acrochordon *  1/570 (0.18%)  1
dysplastic naevus *  1/570 (0.18%)  1
melanocytic naevus *  1/570 (0.18%)  1
seborrhoeic keratosis *  1/570 (0.18%)  1
Nervous system disorders   
Headache *  75/570 (13.16%)  94
Migraine *  4/570 (0.70%)  6
Tension headache *  2/570 (0.35%)  2
dizziness *  1/570 (0.18%)  1
hypoaesthesia *  1/570 (0.18%)  1
paraesthesia *  1/570 (0.18%)  1
presyncope *  1/570 (0.18%)  1
radiculitis cervical *  1/570 (0.18%)  1
Psychiatric disorders   
Anxiety *  2/570 (0.35%)  2
Depression *  4/570 (0.70%)  4
adjustment disorder with depressed mood *  1/570 (0.18%)  1
attention deficit/hyperactivity disorder *  1/570 (0.18%)  1
insomnia *  1/570 (0.18%)  1
Renal and urinary disorders   
nephrolithiasis *  1/570 (0.18%)  1
proteinuria *  1/570 (0.18%)  1
Reproductive system and breast disorders   
breast tenderness *  1/570 (0.18%)  1
vaginal discharge *  1/570 (0.18%)  1
vaginal haemorrhage *  1/570 (0.18%)  1
Respiratory, thoracic and mediastinal disorders   
Cough *  7/570 (1.23%)  7
Oropharyngeal pain *  2/570 (0.35%)  2
asthma *  1/570 (0.18%)  1
nasal congestion *  1/570 (0.18%)  1
pulmonary mass *  1/570 (0.18%)  1
sinus congestion *  1/570 (0.18%)  1
sinus disorder *  1/570 (0.18%)  1
upper-airway cough syndrome *  1/570 (0.18%)  1
Skin and subcutaneous tissue disorders   
Acne *  6/570 (1.05%)  6
Actinic keratosis *  3/570 (0.53%)  3
Dermatitis contact *  6/570 (1.05%)  6
Eczema *  2/570 (0.35%)  2
Pruritus *  2/570 (0.35%)  3
Solar lentigo *  2/570 (0.35%)  2
Dry skin *  1/570 (0.18%)  1
Ecchymosis *  1/570 (0.18%)  1
Erythema *  1/570 (0.18%)  1
Post inflammatory pigmentation change *  1/570 (0.18%)  1
Rash *  1/570 (0.18%)  1
Rash papular *  1/570 (0.18%)  1
Rash pruritic *  1/570 (0.18%)  1
Rosacea *  1/570 (0.18%)  1
Skin mass *  1/570 (0.18%)  1
Skin swelling *  1/570 (0.18%)  1
Social circumstances   
menopause *  2/570 (0.35%)  2
Vascular disorders   
Hot flush *  1/570 (0.18%)  1
Hypertension *  10/570 (1.75%)  10
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rui L. Avelar, MD
Organization: Evolus, Inc
Phone: (805)689-8668
Responsible Party: Evolus, Inc.
ClinicalTrials.gov Identifier: NCT02428608     History of Changes
Other Study ID Numbers: Evolus - CLIN006
First Submitted: April 21, 2015
First Posted: April 29, 2015
Results First Submitted: January 11, 2019
Results First Posted: February 5, 2019
Last Update Posted: April 24, 2019