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Trial record 2 of 724 for:    Botulinum Toxins, Type A

A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001

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ClinicalTrials.gov Identifier: NCT02334423
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : February 26, 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 330
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

Period Title: Overall Study
Started 246 84
Completed 236 81
Not Completed 10 3
Reason Not Completed
Protocol Violation             10             3
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

Total of all reporting groups
Overall Number of Baseline Participants 246 84 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 84 participants 330 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
220
  89.4%
75
  89.3%
295
  89.4%
>=65 years
26
  10.6%
9
  10.7%
35
  10.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 84 participants 330 participants
Female
227
  92.3%
79
  94.0%
306
  92.7%
Male
19
   7.7%
5
   6.0%
24
   7.3%
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
c
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

Overall Number of Participants Analyzed 246 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
67.5
(61.2 to 73.4)
1.2
(0.0 to 6.5)
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 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
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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

Overall Number of Participants Analyzed 246 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
8.3
(5.1 to 12.7)
1.3
(0.0 to 6.8)
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
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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
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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

Overall Number of Participants Analyzed 246 84
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 4.5)
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 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 Day 90
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

Overall Number of Participants Analyzed 246 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
26.5
(21.0 to 32.6)
1.3
(0.0 to 6.8)
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

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   3/246 (1.22%)      0/84 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma *  1/246 (0.41%)  1 0/84 (0.00%)  0
Uterine cancer *  1/246 (0.41%)  1 0/84 (0.00%)  0
Nervous system disorders     
Intracranial aneurysm *  1/246 (0.41%)  1 0/84 (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   91/246 (36.99%)      27/84 (32.14%)    
Blood and lymphatic system disorders     
Anemia *  1/246 (0.41%)  1 1/84 (1.19%)  1
Cardiac disorders     
Palpitations *  1/246 (0.41%)  1 0/84 (0.00%)  0
Eye disorders     
Asthenopia *  2/246 (0.81%)  2 0/84 (0.00%)  0
Eyebrow ptosis *  1/246 (0.41%)  1 0/84 (0.00%)  0
Eyelid ptosis *  4/246 (1.63%)  4 0/84 (0.00%)  0
Vision blurred *  1/246 (0.41%)  1 0/84 (0.00%)  0
Eye allergy *  1/246 (0.41%)  1 0/84 (0.00%)  0
Contact Lense Intolerance *  0/246 (0.00%)  0 1/84 (1.19%)  1
Glaucoma *  0/246 (0.00%)  0 1/84 (1.19%)  1
Lacrimation Increased *  0/246 (0.00%)  0 1/84 (1.19%)  1
Gastrointestinal disorders     
Food poisoning *  1/246 (0.41%)  1 0/84 (0.00%)  0
Nausea *  1/246 (0.41%)  1 0/84 (0.00%)  0
Toothache *  1/246 (0.41%)  1 0/84 (0.00%)  0
Vomiting *  1/246 (0.41%)  1 0/84 (0.00%)  0
General disorders     
Pain *  1/246 (0.41%)  1 0/84 (0.00%)  0
Pyrexia *  1/246 (0.41%)  1 0/84 (0.00%)  0
Administration site reaction *  0/246 (0.00%)  0 1/84 (1.19%)  1
Immune system disorders     
Food allergy *  1/246 (0.41%)  1 0/84 (0.00%)  0
Seasonal allergy *  3/246 (1.22%)  5 0/84 (0.00%)  0
Infections and infestations     
Bronchitis *  1/246 (0.41%)  1 1/84 (1.19%)  1
Conjunctivitis *  1/246 (0.41%)  1 0/84 (0.00%)  0
Fungal Infection *  1/246 (0.41%)  1 0/84 (0.00%)  0
Gastroenteritis viral *  1/246 (0.41%)  1 1/84 (1.19%)  1
Hordeolum *  1/246 (0.41%)  2 0/84 (0.00%)  0
Influenza *  2/246 (0.81%)  2 2/84 (2.38%)  2
Localized infection *  1/246 (0.41%)  1 0/84 (0.00%)  0
Lyme disease *  1/246 (0.41%)  1 0/84 (0.00%)  0
Nasopharyngitis *  2/246 (0.81%)  2 0/84 (0.00%)  0
Oral herpes *  1/246 (0.41%)  1 0/84 (0.00%)  0
Pharyngitis *  1/246 (0.41%)  1 0/84 (0.00%)  0
Pharyngitis streptococcal *  1/246 (0.41%)  1 0/84 (0.00%)  0
Sinusitis *  2/246 (0.81%)  2 2/84 (2.38%)  2
Upper respiratory tract infection *  8/246 (3.25%)  8 0/84 (0.00%)  0
Urinary tract infection *  2/246 (0.81%)  2 0/84 (0.00%)  0
Gastroenteritis *  0/246 (0.00%)  0 2/84 (2.38%)  2
Tooth infection *  0/246 (0.00%)  0 1/84 (1.19%)  1
Injury, poisoning and procedural complications     
Arthropod bite *  1/246 (0.41%)  1 0/84 (0.00%)  0
Corneal abrasion *  1/246 (0.41%)  1 0/84 (0.00%)  0
Hand fracture *  1/246 (0.41%)  1 0/84 (0.00%)  0
Muscle strain *  1/246 (0.41%)  1 0/84 (0.00%)  0
Procedural headache *  1/246 (0.41%)  1 0/84 (0.00%)  0
Post-traumatic neck syndrome *  1/246 (0.41%)  1 0/84 (0.00%)  0
Contusion *  2/246 (0.81%)  2 0/84 (0.00%)  0
Stress fracture *  0/246 (0.00%)  0 1/84 (1.19%)  1
Investigations     
Hematocrit increased *  1/246 (0.41%)  1 0/84 (0.00%)  0
Hemoglobin increased *  1/246 (0.41%)  1 0/84 (0.00%)  0
Red blood cell count increased *  1/246 (0.41%)  1 0/84 (0.00%)  0
White blood cell count increased *  6/246 (2.44%)  6 0/84 (0.00%)  0
Occult blood (in urine) *  1/246 (0.41%)  1 1/84 (1.19%)  1
Metabolism and nutrition disorders     
Hypercholesterolemia *  1/246 (0.41%)  1 0/84 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia *  1/246 (0.41%)  1 0/84 (0.00%)  0
Back pain *  1/246 (0.41%)  1 0/84 (0.00%)  0
Muscle spasms *  2/246 (0.81%)  2 0/84 (0.00%)  0
Pain in extremity *  1/246 (0.41%)  1 0/84 (0.00%)  0
Pain in jaw *  1/246 (0.41%)  1 0/84 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign breast neoplasm *  1/246 (0.41%)  1 0/84 (0.00%)  0
Nervous system disorders     
Dizziness *  1/246 (0.41%)  1 0/84 (0.00%)  0
Headache *  36/246 (14.63%)  44 14/84 (16.67%)  18
Migraine *  1/246 (0.41%)  2 0/84 (0.00%)  0
Nerve compression *  1/246 (0.41%)  1 1/84 (1.19%)  1
Paraesthesia *  3/246 (1.22%)  3 0/84 (0.00%)  0
Psychiatric disorders     
Anxiety *  1/246 (0.41%)  1 0/84 (0.00%)  0
Attention deficit/hyperactivity disorder *  1/246 (0.41%)  1 0/84 (0.00%)  0
Insomnia *  1/246 (0.41%)  1 0/84 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma *  1/246 (0.41%)  1 0/84 (0.00%)  0
Cough *  1/246 (0.41%)  1 0/84 (0.00%)  0
Sinus congestion *  1/246 (0.41%)  1 0/84 (0.00%)  0
Dyspnea *  0/246 (0.00%)  0 1/84 (1.19%)  1
Nasal congestion *  0/246 (0.00%)  0 1/84 (1.19%)  1
Angioedema *  0/246 (0.00%)  0 1/84 (1.19%)  1
Skin and subcutaneous tissue disorders     
Acne *  1/246 (0.41%)  1 0/84 (0.00%)  0
Dermatitis contact *  2/246 (0.81%)  2 0/84 (0.00%)  0
Rash *  1/246 (0.41%)  1 0/84 (0.00%)  0
Granuloma annulare *  0/246 (0.00%)  0 1/84 (1.19%)  1
Pain of skin *  0/246 (0.00%)  0 1/84 (1.19%)  1
Vascular disorders     
Flushing *  1/246 (0.41%)  1 0/84 (0.00%)  0
Hypertension *  2/246 (0.81%)  2 1/84 (1.19%)  1
Thrombosis *  1/246 (0.41%)  1 0/84 (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: NCT02334423     History of Changes
Other Study ID Numbers: EV-001
First Submitted: January 6, 2015
First Posted: January 8, 2015
Results First Submitted: January 4, 2019
Results First Posted: February 26, 2019
Last Update Posted: March 27, 2019