Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines (EV-004)

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: NCT02184988
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : February 5, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Evolus, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glabellar Frown Lines
Intervention Biological: Botulinum purified neurotoxin, Type A
Enrollment 352
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Neurotoxin, Type A
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 352
Completed 297
Not Completed 55
Reason Not Completed
Pregnancy             2
Adverse Event             2
moving away/travelling/unable to complet             6
work scheduling issues             4
various other reasons             9
Lost to Follow-up             32
Arm/Group Title Botulinum Neurotoxin, Type A
Hide Arm/Group Description

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 Number of Baseline Participants 352
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 352 participants
<=18 years
0
   0.0%
Between 18 and 65 years
319
  90.6%
>=65 years
33
   9.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 352 participants
Female
331
  94.0%
Male
21
   6.0%
1.Primary Outcome
Title The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
Hide Description 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.
Time Frame 365 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botulinum Neurotoxin, Type A
Hide Arm/Group Description:

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 Number of Participants Analyzed 352
Measure Type: Count of Participants
Unit of Measure: Participants
148
  42.0%
2.Other Pre-specified Outcome
Title 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)
Hide Description 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
Time Frame 365 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Botulinum Neurotoxin, Type A
Hide Arm/Group Description:

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 Number of Participants Analyzed 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
75.9
(70.6 to 80.7)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Neurotoxin, Type A
Hide Arm/Group Description

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.

All-Cause Mortality
Botulinum Neurotoxin, Type A
Affected / at Risk (%)
Total   0/352 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Neurotoxin, Type A
Affected / at Risk (%) # Events
Total   7/352 (1.99%)    
Gastrointestinal disorders   
Pancreatitis *  1/352 (0.28%)  1
General disorders   
Device failure – failure of pacemaker/defibrillator *  1/352 (0.28%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma *  2/352 (0.57%)  2
Breast cancer *  1/352 (0.28%)  1
Malignant anorectal neoplasm *  1/352 (0.28%)  1
Ovarian Adenoma *  1/352 (0.28%)  1
Reproductive system and breast disorders   
Dysfunctional uterine bleeding *  1/352 (0.28%)  2
*
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 Neurotoxin, Type A
Affected / at Risk (%) # Events
Total   141/352 (40.06%)    
Cardiac disorders   
atrial tachycardia *  1/352 (0.28%)  1
palpitations *  1/352 (0.28%)  1
Ear and labyrinth disorders   
ear congestion *  1/352 (0.28%)  1
Eye disorders   
Asthenopia *  2/352 (0.57%)  3
Blepharospasm *  1/352 (0.28%)  1
Dry eye *  1/352 (0.28%)  1
Eyelid edema *  2/352 (0.57%)  2
Eyelid ptosis *  5/352 (1.42%)  5
Lacrimation increased *  2/352 (0.57%)  2
Presbyopia *  1/352 (0.28%)  1
Gastrointestinal disorders   
Hemorrhoids *  2/352 (0.57%)  2
diarrhea *  1/352 (0.28%)  1
dyspepsia *  1/352 (0.28%)  1
gastro-esophageal reflux disease *  1/352 (0.28%)  1
large intestine polyp *  1/352 (0.28%)  1
nausea *  1/352 (0.28%)  1
pancreatic cyst *  1/352 (0.28%)  1
pancreatic pseudocyst *  1/352 (0.28%)  1
toothache *  1/352 (0.28%)  1
General disorders   
Influenza like illness *  2/352 (0.57%)  2
Injection site bruising *  4/352 (1.14%)  4
Injection site pain *  4/352 (1.14%)  4
chest pain *  1/352 (0.28%)  1
fatigue *  1/352 (0.28%)  1
injection site cyst *  1/352 (0.28%)  1
injection site laceration *  1/352 (0.28%)  1
injury associated with a device *  1/352 (0.28%)  1
Immune system disorders   
hypersensitivity *  1/352 (0.28%)  1
seasonal allergy *  1/352 (0.28%)  1
Infections and infestations   
Bronchitis *  8/352 (2.27%)  8
Diverticulitis *  2/352 (0.57%)  2
Influenza *  9/352 (2.56%)  9
Gastroenteritis viral *  5/352 (1.42%)  5
Nasopharyngitis *  4/352 (1.14%)  4
Sinusitis *  12/352 (3.41%)  12
Tooth infection *  2/352 (0.57%)  2
Upper respiratory tract infection *  4/352 (1.14%)  4
Urinary tract infection *  9/352 (2.56%)  9
abscess limb *  1/352 (0.28%)  1
cystitis *  1/352 (0.28%)  1
ear infection *  1/352 (0.28%)  1
herpes zoster *  1/352 (0.28%)  1
laryngitis *  1/352 (0.28%)  1
oral candidiasis *  1/352 (0.28%)  1
oral herpes *  1/352 (0.28%)  1
pharyngitis *  1/352 (0.28%)  1
pharyngitis streptococcal *  1/352 (0.28%)  1
tinea faciei *  1/352 (0.28%)  1
viral infection *  1/352 (0.28%)  1
Injury, poisoning and procedural complications   
Ligament sprain *  2/352 (0.57%)  2
Meniscus injury *  2/352 (0.57%)  2
arthropod bite *  1/352 (0.28%)  1
fall *  1/352 (0.28%)  1
incision site pain *  1/352 (0.28%)  1
limb injury *  1/352 (0.28%)  1
lip injury *  1/352 (0.28%)  1
median nerve injury *  1/352 (0.28%)  1
post procedural swelling *  1/352 (0.28%)  1
road traffic accident *  1/352 (0.28%)  1
thermal burn *  1/352 (0.28%)  1
wrist fracture *  1/352 (0.28%)  1
Investigations   
glucose in urine *  1/352 (0.28%)  1
Metabolism and nutrition disorders   
decreased appetite *  1/352 (0.28%)  1
diabetes mellitus *  1/352 (0.28%)  1
hypercholesterolemia *  1/352 (0.28%)  1
hyperlipidemia *  1/352 (0.28%)  1
Vitamin D deficiency *  1/352 (0.28%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms *  2/352 (0.57%)  2
arthralgia *  1/352 (0.28%)  1
bursitis *  1/352 (0.28%)  1
myalgia *  1/352 (0.28%)  1
osteoarthritis *  1/352 (0.28%)  1
osteoporosis *  1/352 (0.28%)  1
pain in extremity *  1/352 (0.28%)  1
pain in jaw *  1/352 (0.28%)  1
rheumatoid arthritis *  1/352 (0.28%)  1
tendonitis *  1/352 (0.28%)  1
tenosynovitis *  1/352 (0.28%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma *  1/352 (0.28%)  1
Melanocytic nevus *  2/352 (0.57%)  2
benign breast neoplasm *  1/352 (0.28%)  1
ovarian adenoma *  1/352 (0.28%)  1
Nervous system disorders   
Headache *  54/352 (15.34%)  65
Lethargy *  2/352 (0.57%)  2
Muscle tone disorder *  2/352 (0.57%)  2
Sinus headache *  2/352 (0.57%)  2
Speech disorder *  2/352 (0.57%)  2
Dizziness *  1/352 (0.28%)  1
Migraine *  1/352 (0.28%)  1
Migraine with aura *  1/352 (0.28%)  1
Nerve compression *  1/352 (0.28%)  1
Paresthesia *  1/352 (0.28%)  1
Post herpetic neuralgia *  1/352 (0.28%)  1
Thoracic outlet syndrome *  1/352 (0.28%)  1
Psychiatric disorders   
Depression *  2/352 (0.57%)  2
Insomnia *  2/352 (0.57%)  2
anxiety *  1/352 (0.28%)  1
ADHD *  1/352 (0.28%)  1
Renal and urinary disorders   
nephrolithiasis *  2/352 (0.57%)  2
Reproductive system and breast disorders   
vulvovaginal swelling *  1/352 (0.28%)  1
Endometrial Hyperplasia *  1/352 (0.28%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  2/352 (0.57%)  2
asthma *  1/352 (0.28%)  1
cough *  1/352 (0.28%)  1
nasal congestion *  1/352 (0.28%)  1
sinus congestion *  1/352 (0.28%)  1
Skin and subcutaneous tissue disorders   
Dermal cyst *  1/352 (0.28%)  2
acne *  1/352 (0.28%)  1
dermatitis *  1/352 (0.28%)  1
dermatitis contact *  1/352 (0.28%)  1
ecchymosis *  1/352 (0.28%)  1
psoriasis *  1/352 (0.28%)  1
rosacea *  1/352 (0.28%)  1
skin tightening *  1/352 (0.28%)  1
skin wrinkling *  1/352 (0.28%)  1
Vascular disorders   
hypertension *  4/352 (1.14%)  4
*
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
Layout table for Results Point of Contact information
Name/Title: Rui L. Avelar, MD
Organization: Evolus, Inc
Phone: (805)689-8668
EMail: rui@evolusinc.com
Layout table for additonal information
Responsible Party: Evolus, Inc.
ClinicalTrials.gov Identifier: NCT02184988     History of Changes
Other Study ID Numbers: Evolus - CLIN004
First Submitted: July 2, 2014
First Posted: July 9, 2014
Results First Submitted: January 11, 2019
Results First Posted: February 5, 2019
Last Update Posted: April 24, 2019