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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Biological: DWP-450 (Botulinum purified neurotoxin, Type A)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin, Tyoe A<br>DWP-450 (Botulinum toxin, Type A) | Biological: DWP-450 (Botulinum purified neurotoxin, Type A)<br>* Botulinum toxin, Type A<br>* Other names: DWP-450;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glabellar Lines, Botulinum toxin, Type A