Clinical trial NCT02184988: Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines
Official title: A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Keywords: Glabellar Lines
Botulinum purifies neurotoxin, Type A (DWP-450)
Lead sponsor: Evolus, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
timeFrame: 365 Days
Secondary outcomes:
Other outcomes:
measure: 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)
timeFrame: 365 Days
Locations:
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
Study officials:
affiliation: Evolus, Inc.
name: Rui Avelar, MD
role: STUDY_DIRECTOR
References:
citation: 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.