CompletedNCT02184988EV-004Updated Apr 24, 2019Results posted

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

A Phase 2 interventional study of Botulinum purified neurotoxin, Type A in Glabellar Frown Lines, sponsored by Evolus, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-24.

Sponsored by Evolus, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 352
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.

Read the detailed description

Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.

Subjects with moderate or severe glabellar lines at maximum frown on the 4 point Glabellar Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will be eligible for injection with DWP-450. After each injection, subjects will be followed and are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible for repeat treatment.

Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from initial treatment.

Conditions studied

Glabellar Frown Lines

Keywords

Glabellar Lines
Botulinum purifies neurotoxin, Type A (DWP-450)

In context

Lead sponsor

Evolus, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study):

Subjects must be an adult 18 years of age or over
Subject is able to provide informed consent and comply with study instructions
Subject has moderate to severe glabellar lines on maximum frown as assessed by the investigator using the GLS
Subject is willing and able to complete the entire course of the study

Exclusion Criteria (A subject must not meet the following exclusion criteria in order to be eligible for enrollment in the stud)y:

Previous treatment with botulinum toxin of any serotype in the forehead area within the last 8 months
Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
Previous insertion of permanent material in the glabellar area
Planned treatment with botulinum toxin of any serotype in any other body region during the study period
Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
Energy based or cryo-therapy based treatment of facial muscles superior to the lateral canthus
Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
Inability to substantially lessen glabellar frown lines even by physically spreading them apart
Marked facial asymmetry
Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis
History of facial nerve palsy
Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin
Any active infection in the area of the injection sites
Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
Evidence of recent alcohol or drug abuse
Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
Known allergy or hypersensitivity to botulinum toxin preparation
Participation in another interventional clinical study within the last 30 days

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 352 participants (actual)

Study arms

Experimental
Botulinum neurotoxin, Type A
DWP-450 (Botulinum purified neurotoxin, Type A) Injection
Biological: Botulinum purified neurotoxin, Type A

Interventions

BiologicalBotulinum 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.
Also known as: DWP-450 (Botulinum purified neurotoxin, Type A) Injection

What researchers measure

Primary outcomes

The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
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

Other outcomes

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)
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

Results

Posted Feb 5, 2019

Participant flow

Participant flow — Overall Study
Milestone	Botulinum Neurotoxin, Type A
Started	352
Completed	297
Not completed	55
Withdrew: Pregnancy	2
Withdrew: Adverse event	2
Withdrew: Moving away/travelling/unable to complet	6
Withdrew: Work scheduling issues	4
Withdrew: Various other reasons	9
Withdrew: Lost to follow-up	32

Outcome measures

PrimaryThe Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year

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
Reported as:: Count of participants · Participants

The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
Participants	Botulinum Neurotoxin, Type A
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year	148

Other pre-specifiedPercentage 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)

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
Reported as:: Number · percentage of responders

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)
percentage of responders	Botulinum Neurotoxin, Type A
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)	75.9 (70.6 to 80.7)

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Botulinum Neurotoxin, Type A	0/352 (0%)	7/352 (2%)	141/352 (40.1%)

Most frequent serious events

Most frequent serious events
Event	Botulinum Neurotoxin, Type A
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/352
Device failure - failure of pacemaker/defibrillatorGeneral disorders	1/352
PancreatitisGastrointestinal disorders	1/352
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/352
Malignant anorectal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/352
Dysfunctional uterine bleedingReproductive system and breast disorders	1/352
Ovarian AdenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/352

Most frequent other events

Showing 10 of 116

Most frequent other events
Event	Botulinum Neurotoxin, Type A
HeadacheNervous system disorders	54/352
SinusitisInfections and infestations	12/352
InfluenzaInfections and infestations	9/352
Urinary tract infectionInfections and infestations	9/352
BronchitisInfections and infestations	8/352
Gastroenteritis viralInfections and infestations	5/352
Eyelid ptosisEye disorders	5/352
NasopharyngitisInfections and infestations	4/352
Upper respiratory tract infectionInfections and infestations	4/352
Injection site bruisingGeneral disorders	4/352

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Botulinum Neurotoxin, Type A
<=18 years	0
Between 18 and 65 years	319
>=65 years	33

Sex: Female, Male
Sex: Female, Male(Participants)	Botulinum Neurotoxin, Type A
Female	331
Male	21

Study locations

1 site

ATS Clinical Research
Santa Monica, California 90404, United States

References and documents

Publications

Nam HS, Park YG, Paik NJ, Oh BM, Chun MH, Yang HE, Kim DH, Yi Y, Seo HG, Kim KD, Chang MC, Ryu JH, Lee SU. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. J Neurol Sci. 2015 Oct 15;357(1-2):192-7. doi: 10.1016/j.jns.2015.07.028. Epub 2015 Jul 21. PubMed 26233808 ↗

Individual participant data

Plan to share: No — Analysis will be of combined data for all subjects entered into the study

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02184988
Lead sponsor: Evolus, Inc.
Responsible party: Sponsor
First posted: Jul 9, 2014
Start date: Aug 2014
Primary completion: Dec 2015
Completion: Dec 2015
Results posted: Feb 5, 2019
Last update: Apr 24, 2019

Study contacts

Rui Avelar, MD

study director · Evolus, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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