Trial Outcomes & Findings for A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001 (NCT NCT02334423)
NCT ID: NCT02334423
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
330 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
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
84
|
|
Overall Study
COMPLETED
|
236
|
81
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| 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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
10
|
3
|
Baseline Characteristics
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001
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=84 Participants
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
Total
n=330 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
|
220 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
227 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: c
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=246 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=84 Participants
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
67.5 percentage of responders
Interval 61.2 to 73.4
|
1.2 percentage of responders
Interval 0.0 to 6.5
|
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=246 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=84 Participants
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
8.3 percentage of responders
Interval 5.1 to 12.7
|
1.3 percentage of responders
Interval 0.0 to 6.8
|
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=246 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=84 Participants
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
|---|---|---|
|
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 4.5
|
SECONDARY outcome
Timeframe: Day 90Population: 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=246 Participants
Botulinum toxin, Type A
Botulinum toxin, Type A: Botulinum toxin, Type A
|
Placebo
n=84 Participants
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
|---|---|---|
|
Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
|
26.5 percentage of responders
Interval 21.0 to 32.6
|
1.3 percentage of responders
Interval 0.0 to 6.8
|
Adverse Events
Botulinum Toxin, Type A
Serious events: 3 serious events
Other events: 91 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 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=84 participants at risk
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Intracranial aneurysm
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
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=84 participants at risk
0.9 % sterile, unpreserved saline
0.9% sterile, unpreserved saline: Placebo
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Nervous system disorders
Headache
|
14.6%
36/246 • Number of events 44
|
16.7%
14/84 • Number of events 18
|
|
Nervous system disorders
Migraine
|
0.41%
1/246 • Number of events 2
|
0.00%
0/84
|
|
Nervous system disorders
Nerve compression
|
0.41%
1/246 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
1.2%
3/246 • Number of events 3
|
0.00%
0/84
|
|
Infections and infestations
Bronchitis
|
0.41%
1/246 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Fungal Infection
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Gastroenteritis viral
|
0.41%
1/246 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.41%
1/246 • Number of events 2
|
0.00%
0/84
|
|
Infections and infestations
Influenza
|
0.81%
2/246 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Localized infection
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Lyme disease
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Nasopharyngitis
|
0.81%
2/246 • Number of events 2
|
0.00%
0/84
|
|
Infections and infestations
Oral herpes
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Pharyngitis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Infections and infestations
Sinusitis
|
0.81%
2/246 • Number of events 2
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
8/246 • Number of events 8
|
0.00%
0/84
|
|
Infections and infestations
Urinary tract infection
|
0.81%
2/246 • Number of events 2
|
0.00%
0/84
|
|
Eye disorders
Asthenopia
|
0.81%
2/246 • Number of events 2
|
0.00%
0/84
|
|
Eye disorders
Eyebrow ptosis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Eye disorders
Eyelid ptosis
|
1.6%
4/246 • Number of events 4
|
0.00%
0/84
|
|
Eye disorders
Vision blurred
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Eye disorders
Eye allergy
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Hematocrit increased
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Hemoglobin increased
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Investigations
Red blood cell count increased
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Investigations
White blood cell count increased
|
2.4%
6/246 • Number of events 6
|
0.00%
0/84
|
|
Investigations
Occult blood (in urine)
|
0.41%
1/246 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.81%
2/246 • Number of events 2
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Food poisoning
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Nausea
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Toothache
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.81%
2/246 • Number of events 2
|
0.00%
0/84
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Flushing
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Vascular disorders
Hypertension
|
0.81%
2/246 • Number of events 2
|
1.2%
1/84 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Immune system disorders
Food allergy
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Immune system disorders
Seasonal allergy
|
1.2%
3/246 • Number of events 5
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Psychiatric disorders
Anxiety
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Psychiatric disorders
Insomnia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
General disorders
Pain
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
General disorders
Pyrexia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Blood and lymphatic system disorders
Anemia
|
0.41%
1/246 • Number of events 1
|
1.2%
1/84 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.41%
1/246 • Number of events 1
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Contusion
|
0.81%
2/246 • Number of events 2
|
0.00%
0/84
|
|
Eye disorders
Contact Lense Intolerance
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
General disorders
Administration site reaction
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/246
|
2.4%
2/84 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Angioedema
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/246
|
1.2%
1/84 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place