A clinical trial demonstrating the safety and efficacy of treatment of lines between the eye brows with the test drug DWP-450 in adults by comparison with Botox and Placebo.

Phase 1

Conditions: moderate-to-severe glabellar lines
MedDRA version: 17.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-001063-12-GB

Lead Sponsor: Evolus Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 497

Inclusion Criteria

-Subject is an adult, of at least 18 years of age
-Subject understands and signs the informed consent and can comply with study instructions
-Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS (GLS=2 or 3)
-Subject is willing and able to complete the entire course of the study
-Subject finds their glabellar lines have an important psychological impact (on mood, anxiety and/or depressive symptoms)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 435
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

A subject must not meet the following key exclusion criteria in order to be eligible for enrollment in the study:
-Previous treatment with botulinum toxin of any serotype in the forehead 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 (can continue with their usual skin care routine)
-Subjects not reasonably expected to respond to 20 units of botulinum toxin (e.g., 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 or history of herpes simplex or herpes zoster in the area of the injection sites
-Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
-History of dysphagia or aspiration
-Subjects with prolonged bleeding times. If on a drug or supplement that prolongs bleeding times (eg non-steroidal, anti-inflammatory, anticoagulant, fish oil), wait 10 days or until bleeding times return to normal before injecting
-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
-Breast feeding, pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
-Individuals who may be unduly influenced or fear a retaliatory response by hierarchy at the study center during the study
-Known allergy or hypersensitivity to botulinum toxin preparation
-Participation in another interventional clinical study within the last 30 days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to demonstrate the safety and efficacy of DWP-450 purified botulinum neurotoxin, Type A in treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects at maximum frown.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy measure will be based on the investigators assessment of the subject using the four-point Glabellar Line Scale (0=none, 1=mild, 2=moderate, 3=severe) at maximum frown. The primary endpoint for assessing the efficacy of DWP-450 is the proportion of subjects with a GLS score of 0 or 1 on Day 30 (±3 days), post injection of a study drug.;Timepoint(s) of evaluation of this end point: Day 30 (±3 days)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Proportion of subjects with at least a 1 point improvement in the GLS from Day 0 to Day 2 at maximum frown by Investigator assessment<br>2) Proportion of subjects with a GLS score of 0 or 1 on Day 30, at maximum frown by subject assessment<br>3) Proportion of subjects with at least a 1 point improvement in Subject Satisfaction from Day 0 to Day 30 (±3 days)<br>4) Difference between the mean HAD Scale scores from Day 0 to Day 90<br>5) Proportion of subjects with at least a 1 point improvement in the GLS from Day 0 to Day 150 at maximum frown by Investigator assessment;Timepoint(s) of evaluation of this end point: 1) Day 0-2<br>2) Day 30<br>3) Day 30 (±3 days)<br>4) Day 90<br>5) Day 150

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