Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: DWP-450 (Botulinum purified neurotoxin, Type A)

• Registration Number: NCT02428608
• Lead Sponsor: Evolus, Inc.

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.

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Study Start: 2015-05
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Disposition First Submitted: 2017-02-01
• Disposition First Submitted QC: 2017-03-20
• Disposition First Posted: 2017-03-21
• Results First Submitted: 2019-01-11
• Results First Submitted QC: 2019-01-11
• Results First Posted: 2019-02-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum toxin, Tyoe A	DWP-450 (Botulinum purified neurotoxin, Type A)	DWP-450 (Botulinum toxin, Type A)

Primary Outcome Measures

Name	Time	Method
The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year	365 days	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.

Trial Locations

Locations (1)

The Advanced Skin Research Center at Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States