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A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002 (EV-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02334436
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : February 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Evolus, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Glabellar Frown Lines
Interventions Biological: Botulinum toxin, Type A
Other: 0.9% sterile, unpreserved saline
Enrollment 324
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin, Type A Placebo
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Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

Period Title: Overall Study
Started 246 78
Completed 237 77
Not Completed 9 1
Arm/Group Title Botulinum Toxin, Type A Placebo Total
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Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

Total of all reporting groups
Overall Number of Baseline Participants 246 78 324
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 78 participants 324 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
219
  89.0%
72
  92.3%
291
  89.8%
>=65 years
27
  11.0%
6
   7.7%
33
  10.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants 78 participants 324 participants
51.5  (11.54) 50.4  (10.14) 51.2  (11.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 78 participants 324 participants
Female
220
  89.4%
70
  89.7%
290
  89.5%
Male
26
  10.6%
8
  10.3%
34
  10.5%
1.Primary Outcome
Title Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
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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.

Time Frame Day 30
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Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Botulinum Toxin, Type A Placebo
Hide Arm/Group Description:

Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

Overall Number of Participants Analyzed 240 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
70.4
(64.2 to 76.1)
1.3
(0.0 to 7.2)
2.Secondary Outcome
Title Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
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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.

Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Botulinum Toxin, Type A Placebo
Hide Arm/Group Description:

Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

Overall Number of Participants Analyzed 233 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
25.8
(20.3 to 31.9)
0.0
(0.0 to 4.7)
3.Secondary Outcome
Title Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
Hide Description

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.

Time Frame Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Botulinum Toxin, Type A Placebo
Hide Arm/Group Description:

Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

Overall Number of Participants Analyzed 233 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
12.4
(8.5 to 17.4)
0.0
(0.0 to 4.8)
4.Secondary Outcome
Title Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
Hide Description

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.

Time Frame Day 150
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Botulinum Toxin, Type A Placebo
Hide Arm/Group Description:

Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

Overall Number of Participants Analyzed 237 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
4.6
(2.3 to 8.2)
0.0
(0.0 to 4.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin, Type A Placebo
Hide Arm/Group Description

Botulinum toxin, Type A

Botulinum toxin, Type A: Botulinum toxin, Type A

0.9% sterile, unpreserved saline

0.9% sterile, unpreserved saline: Placebo Comparator Arm

All-Cause Mortality
Botulinum Toxin, Type A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin, Type A Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/246 (1.63%)      0/78 (0.00%)    
Cardiac disorders     
Stress-induced cardiomyopathy *  1/246 (0.41%)  1 0/78 (0.00%)  0
Injury, poisoning and procedural complications     
Femur fracture *  1/246 (0.41%)  1 0/78 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer *  1/246 (0.41%)  1 0/78 (0.00%)  0
Nervous system disorders     
Transient ischemic attack *  1/246 (0.41%)  1 0/78 (0.00%)  0
*
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 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/246 (26.83%)      21/78 (26.92%)    
Cardiac disorders     
Atrial fibrillation *  1/246 (0.41%)  1 0/78 (0.00%)  0
Palpitations *  1/246 (0.41%)  1 0/78 (0.00%)  0
Supraventricular tachycardia *  1/246 (0.41%)  1 0/78 (0.00%)  0
Endocrine disorders     
Hypothyroidism *  1/246 (0.41%)  1 1/78 (1.28%)  1
Eye disorders     
Eye pruritus *  0/246 (0.00%)  0 1/78 (1.28%)  1
Eyelid edema *  2/246 (0.81%)  2 0/78 (0.00%)  0
Eyelid ptosis *  4/246 (1.63%)  4 0/78 (0.00%)  0
Blepharospasm *  1/246 (0.41%)  1 0/78 (0.00%)  0
Asthenopia *  1/246 (0.41%)  1 0/78 (0.00%)  0
Diplopia *  1/246 (0.41%)  1 0/78 (0.00%)  0
Eye pain *  1/246 (0.41%)  1 0/78 (0.00%)  0
Keratitis *  1/246 (0.41%)  1 0/78 (0.00%)  0
Vision blurred *  1/246 (0.41%)  1 0/78 (0.00%)  0
Eyebrow ptosis *  2/246 (0.81%)  2 0/78 (0.00%)  0
Eye irritation *  0/246 (0.00%)  0 1/78 (1.28%)  1
Gastrointestinal disorders     
Constipation *  1/246 (0.41%)  1 0/78 (0.00%)  0
Diarrhea *  1/246 (0.41%)  1 0/78 (0.00%)  0
Crohn's disease *  0/246 (0.00%)  0 1/78 (1.28%)  1
Nausea *  0/246 (0.00%)  0 2/78 (2.56%)  2
General disorders     
Injection site bruising *  3/246 (1.22%)  3 0/78 (0.00%)  0
Injection site pain *  2/246 (0.81%)  2 0/78 (0.00%)  0
Injection site swelling *  1/246 (0.41%)  1 0/78 (0.00%)  0
Infections and infestations     
Bronchitis *  2/246 (0.81%)  2 0/78 (0.00%)  0
Cystitis *  1/246 (0.41%)  1 0/78 (0.00%)  0
Gastroenteritis *  2/246 (0.81%)  2 0/78 (0.00%)  0
Gastroenteritis viral *  2/246 (0.81%)  2 2/78 (2.56%)  2
Herpes zoster *  1/246 (0.41%)  1 0/78 (0.00%)  0
Laryngitis *  1/246 (0.41%)  1 0/78 (0.00%)  0
Nasopharyngitis *  3/246 (1.22%)  3 1/78 (1.28%)  1
Pharyngitis *  1/246 (0.41%)  1 0/78 (0.00%)  0
Pharyngitis streptococcal *  2/246 (0.81%)  2 0/78 (0.00%)  0
Pneumonia *  1/246 (0.41%)  1 0/78 (0.00%)  0
Sinusitis *  2/246 (0.81%)  2 2/78 (2.56%)  2
Upper respiratory tract infection *  5/246 (2.03%)  5 1/78 (1.28%)  1
Urinary tract infection *  3/246 (1.22%)  4 0/78 (0.00%)  0
Fungal infection *  0/246 (0.00%)  0 1/78 (1.28%)  1
Pneumonia mycoplasmal *  0/246 (0.00%)  0 1/78 (1.28%)  1
Post procedural infection *  0/246 (0.00%)  0 1/78 (1.28%)  1
Injury, poisoning and procedural complications     
Arthropod bite *  1/246 (0.41%)  1 0/78 (0.00%)  0
Contusion *  2/246 (0.81%)  2 1/78 (1.28%)  1
Ligament rupture *  1/246 (0.41%)  2 0/78 (0.00%)  0
Muscle strain *  2/246 (0.81%)  2 1/78 (1.28%)  1
Rib fracture *  1/246 (0.41%)  1 0/78 (0.00%)  0
Tooth abcess *  0/246 (0.00%)  0 1/78 (1.28%)  1
Laceration *  0/246 (0.00%)  0 1/78 (1.28%)  1
Ligament sprain *  0/246 (0.00%)  0 1/78 (1.28%)  1
Meniscus injury *  0/246 (0.00%)  0 1/78 (1.28%)  1
Investigations     
Blood glucose increased *  1/246 (0.41%)  1 0/78 (0.00%)  0
Glucose urine present *  1/246 (0.41%)  1 0/78 (0.00%)  0
Metabolism and nutrition disorders     
Diabetes mellitis *  1/246 (0.41%)  1 0/78 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia *  1/246 (0.41%)  1 1/78 (1.28%)  1
Musculoskeletal pain *  1/246 (0.41%)  1 1/78 (1.28%)  1
Myalgia *  2/246 (0.81%)  2 0/78 (0.00%)  0
Rheumatoid arthritis *  2/246 (0.81%)  2 0/78 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma *  1/246 (0.41%)  1 0/78 (0.00%)  0
Nervous system disorders     
Headache *  21/246 (8.54%)  28 7/78 (8.97%)  7
Dizziness *  2/246 (0.81%)  3 0/78 (0.00%)  0
Dysesthesia *  1/246 (0.41%)  1 0/78 (0.00%)  0
Multiple sclerosis relapse *  1/246 (0.41%)  1 0/78 (0.00%)  0
Restless leg syndrome *  1/246 (0.41%)  1 0/78 (0.00%)  0
Sinus headache *  1/246 (0.41%)  1 0/78 (0.00%)  0
Syncope *  1/246 (0.41%)  1 0/78 (0.00%)  0
Renal and urinary disorders     
Urinary incontinence *  1/246 (0.41%)  1 0/78 (0.00%)  0
Nephrolithiasis *  0/246 (0.00%)  0 1/78 (1.28%)  1
Reproductive system and breast disorders     
Adnexa uteri mass *  1/246 (0.41%)  1 0/78 (0.00%)  0
Menopausal symptoms *  1/246 (0.41%)  1 0/78 (0.00%)  0
Menstrual disorder *  1/246 (0.41%)  1 0/78 (0.00%)  0
Metrorrhagia *  1/246 (0.41%)  1 0/78 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Mild wheezing *  1/246 (0.41%)  1 0/78 (0.00%)  0
Mild dyspnea *  1/246 (0.41%)  1 0/78 (0.00%)  0
Epistaxis *  1/246 (0.41%)  1 0/78 (0.00%)  0
Respiratory tract congestion *  2/246 (0.81%)  2 0/78 (0.00%)  0
Throat tightness *  1/246 (0.41%)  1 0/78 (0.00%)  0
Productive cough *  0/246 (0.00%)  0 1/78 (1.28%)  1
Skin and subcutaneous tissue disorders     
Dermatitis acneiform *  1/246 (0.41%)  1 0/78 (0.00%)  0
Dermatitis contact *  1/246 (0.41%)  1 0/78 (0.00%)  0
Papule *  1/246 (0.41%)  1 0/78 (0.00%)  0
Photosensitivity reaction *  1/246 (0.41%)  1 0/78 (0.00%)  0
Rash *  1/246 (0.41%)  1 0/78 (0.00%)  0
Dermatitis *  0/246 (0.00%)  0 1/78 (1.28%)  1
Pruritus *  0/246 (0.00%)  0 1/78 (1.28%)  1
Skin sensitization *  0/246 (0.00%)  0 1/78 (1.28%)  1
Surgical and medical procedures     
Spinal decompression *  1/246 (0.41%)  1 0/78 (0.00%)  0
Vascular disorders     
Hot flush *  1/246 (0.41%)  1 0/78 (0.00%)  0
Hypertension *  1/246 (0.41%)  1 0/78 (0.00%)  0
*
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: NCT02334436     History of Changes
Other Study ID Numbers: EV-002
First Submitted: January 6, 2015
First Posted: January 8, 2015
Results First Submitted: January 4, 2019
Results First Posted: February 27, 2019
Last Update Posted: March 27, 2019