Trial Outcomes & Findings for Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines (NCT NCT02184988)
NCT ID: NCT02184988
Last Updated: 2019-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
352 participants
Primary outcome timeframe
365 Days
Results posted on
2019-04-24
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
352
|
|
Overall Study
COMPLETED
|
297
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
moving away/travelling/unable to complet
|
6
|
|
Overall Study
work scheduling issues
|
4
|
|
Overall Study
various other reasons
|
9
|
|
Overall Study
Lost to Follow-up
|
32
|
Baseline Characteristics
Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines
Baseline characteristics by cohort
| Measure |
Botulinum Neurotoxin, Type A
n=352 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
319 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
331 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 365 DaysThe 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.
Outcome measures
| Measure |
Botulinum Neurotoxin, Type A
n=352 Participants
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.
|
|---|---|
|
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
|
148 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 365 DaysPopulation: 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
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
Outcome measures
| Measure |
Botulinum Neurotoxin, Type A
n=291 Participants
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.
|
|---|---|
|
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)
|
75.9 percentage of responders
Interval 70.6 to 80.7
|
Adverse Events
Botulinum Neurotoxin, Type A
Serious events: 7 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Neurotoxin, Type A
n=352 participants at risk
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.
|
|---|---|
|
General disorders
Device failure - failure of pacemaker/defibrillator
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant anorectal neoplasm
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.28%
1/352 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Adenoma
|
0.28%
1/352 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Botulinum Neurotoxin, Type A
n=352 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Headache
|
15.3%
54/352 • Number of events 65 • 1 year
|
|
Nervous system disorders
Lethargy
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Nervous system disorders
Muscle tone disorder
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Nervous system disorders
Sinus headache
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Nervous system disorders
Speech disorder
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Nervous system disorders
Migraine
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Nervous system disorders
Migraine with aura
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Nervous system disorders
Nerve compression
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Nervous system disorders
Paresthesia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchitis
|
2.3%
8/352 • Number of events 8 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Infections and infestations
Influenza
|
2.6%
9/352 • Number of events 9 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
5/352 • Number of events 5 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
4/352 • Number of events 4 • 1 year
|
|
Infections and infestations
Sinusitis
|
3.4%
12/352 • Number of events 12 • 1 year
|
|
Infections and infestations
Tooth infection
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
4/352 • Number of events 4 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.6%
9/352 • Number of events 9 • 1 year
|
|
Infections and infestations
abscess limb
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
cystitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
ear infection
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
herpes zoster
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
laryngitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
oral candidiasis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
oral herpes
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
pharyngitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
pharyngitis streptococcal
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
tinea faciei
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Infections and infestations
viral infection
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
General disorders
Influenza like illness
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
General disorders
Injection site bruising
|
1.1%
4/352 • Number of events 4 • 1 year
|
|
General disorders
Injection site pain
|
1.1%
4/352 • Number of events 4 • 1 year
|
|
General disorders
chest pain
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
General disorders
fatigue
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
General disorders
injection site cyst
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
General disorders
injection site laceration
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
General disorders
injury associated with a device
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Eye disorders
Asthenopia
|
0.57%
2/352 • Number of events 3 • 1 year
|
|
Eye disorders
Blepharospasm
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Eye disorders
Dry eye
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Eye disorders
Eyelid edema
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Eye disorders
Eyelid ptosis
|
1.4%
5/352 • Number of events 5 • 1 year
|
|
Eye disorders
Lacrimation increased
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Eye disorders
Presbyopia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
osteoporosis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in jaw
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
rheumatoid arthritis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
tenosynovitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
arthropod bite
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
fall
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
incision site pain
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
limb injury
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
lip injury
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
median nerve injury
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
post procedural swelling
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
thermal burn
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
wrist fracture
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
dyspepsia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
gastro-esophageal reflux disease
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
large intestine polyp
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
nausea
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
pancreatic cyst
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
pancreatic pseudocyst
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
toothache
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic nevus
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign breast neoplasm
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ovarian adenoma
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.28%
1/352 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
acne
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
psoriasis
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
rosacea
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin tightening
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin wrinkling
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Psychiatric disorders
anxiety
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Psychiatric disorders
ADHD
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
hyperlipidemia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
vulvovaginal swelling
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Vascular disorders
hypertension
|
1.1%
4/352 • Number of events 4 • 1 year
|
|
Cardiac disorders
atrial tachycardia
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Cardiac disorders
palpitations
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Immune system disorders
hypersensitivity
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Immune system disorders
seasonal allergy
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
ear congestion
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Investigations
glucose in urine
|
0.28%
1/352 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
nephrolithiasis
|
0.57%
2/352 • Number of events 2 • 1 year
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.28%
1/352 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place