Clinical trial NCT02428608: Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006
Official title: A Multi-center, Open Label, Single 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 toxin, Type A
Lead sponsor: Evolus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2015-04-29
Enrollment: 570
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 primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.

Detailed description: Up to five hundred and thirty (530) subjects will be enrolled and injected with the study drug DWP-450 over the course of the 365 day study.

Subjects with moderate-to-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.

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

Eligibility criteria: Inclusion Criteria:

* Subjects must be an adult 18 years of age and 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 and subject using the GLS
* Subject is willing and able to complete the entire course of the study

Exclusion Criteria:

* Previous treatment with botulinum toxin of any serotype in any area within the last 6 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, nursing 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: Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown
timeFrame: 365 days
Locations:
city: Omaha
country: United States
facility: The Advanced Skin Research Center at Skin Specialists, PC
state: Nebraska
Study officials:
affiliation: Evolus, Inc.
name: Rui Avelar, MD
role: STUDY_DIRECTOR
References: