Trial Outcomes & Findings for A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002 (NCT NCT02334436)
NCT ID: NCT02334436
Last Updated: 2019-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
324 participants
Primary outcome timeframe
Day 30
Results posted on
2019-03-27
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin, Type A
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
78
|
|
Overall Study
COMPLETED
|
237
|
77
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002
Baseline characteristics by cohort
| Measure |
Botulinum Toxin, Type A
n=246 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=78 Participants
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
219 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 10.14 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Intent-to-treat
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.
Outcome measures
| Measure |
Botulinum Toxin, Type A
n=240 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=75 Participants
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
70.4 percentage of responders
Interval 64.2 to 76.1
|
1.3 percentage of responders
Interval 0.0 to 7.2
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: Intent-to-treat
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.
Outcome measures
| Measure |
Botulinum Toxin, Type A
n=233 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=76 Participants
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
25.8 percentage of responders
Interval 20.3 to 31.9
|
0.0 percentage of responders
Interval 0.0 to 4.7
|
SECONDARY outcome
Timeframe: Day 120Population: Intent-to-treat
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.
Outcome measures
| Measure |
Botulinum Toxin, Type A
n=233 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=75 Participants
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
12.4 percentage of responders
Interval 8.5 to 17.4
|
0.0 percentage of responders
Interval 0.0 to 4.8
|
SECONDARY outcome
Timeframe: Day 150Population: Intent-to-treat
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.
Outcome measures
| Measure |
Botulinum Toxin, Type A
n=237 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=77 Participants
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
4.6 percentage of responders
Interval 2.3 to 8.2
|
0.0 percentage of responders
Interval 0.0 to 4.7
|
Adverse Events
Botulinum Toxin, Type A
Serious events: 4 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin, Type A
n=246 participants at risk
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=78 participants at risk
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Cardiac disorders
Stress-induced cardiomyopathy
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Nervous system disorders
Transient ischemic attack
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
Other adverse events
| Measure |
Botulinum Toxin, Type A
n=246 participants at risk
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=78 participants at risk
0.9% sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo Comparator Arm
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.5%
21/246 • Number of events 28
|
9.0%
7/78 • Number of events 7
|
|
Eye disorders
Eye pruritus
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Eye disorders
Eyelid edema
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Mild wheezing
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Eyelid ptosis
|
1.6%
4/246 • Number of events 4
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Mild dyspnea
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Blepharospasm
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Nervous system disorders
Dizziness
|
0.81%
2/246 • Number of events 3
|
0.00%
0/78
|
|
Nervous system disorders
Dysesthesia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Nervous system disorders
Restless leg syndrome
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Nervous system disorders
Sinus headache
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Nervous system disorders
Syncope
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Infections and infestations
Bronchitis
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Infections and infestations
Cystitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Infections and infestations
Gastroenteritis
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Infections and infestations
Gastroenteritis viral
|
0.81%
2/246 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Herpes zoster
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Infections and infestations
Laryngitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
3/246 • Number of events 3
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Infections and infestations
Pneumonia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Infections and infestations
Sinusitis
|
0.81%
2/246 • Number of events 2
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
5/246 • Number of events 5
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/246 • Number of events 4
|
0.00%
0/78
|
|
Eye disorders
Asthenopia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Diplopia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Eye pain
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Keratitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Vision blurred
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Eyebrow ptosis
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Contusion
|
0.81%
2/246 • Number of events 2
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.41%
1/246 • Number of events 2
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.81%
2/246 • Number of events 2
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
General disorders
Injection site bruising
|
1.2%
3/246 • Number of events 3
|
0.00%
0/78
|
|
General disorders
Injection site pain
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
General disorders
Injection site swelling
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.41%
1/246 • Number of events 1
|
1.3%
1/78 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.41%
1/246 • Number of events 1
|
1.3%
1/78 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.81%
2/246 • Number of events 2
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Cardiac disorders
Palpitations
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Gastrointestinal disorders
Constipation
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Gastrointestinal disorders
Diarrhea
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Vascular disorders
Hot flush
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Vascular disorders
Hypertension
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Endocrine disorders
Hypothyroidism
|
0.41%
1/246 • Number of events 1
|
1.3%
1/78 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Investigations
Glucose urine present
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Metabolism and nutrition disorders
Diabetes mellitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Renal and urinary disorders
Urinary incontinence
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Surgical and medical procedures
Spinal decompression
|
0.41%
1/246 • Number of events 1
|
0.00%
0/78
|
|
Eye disorders
Eye irritation
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/246
|
2.6%
2/78 • Number of events 2
|
|
Infections and infestations
Fungal infection
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth abcess
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin sensitization
|
0.00%
0/246
|
1.3%
1/78 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place