A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002

NCT ID: NCT02334436

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief Summary

The primary objective is to demonstrate the safety and efficacy of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in the treatment of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult subjects

Detailed Description

Three hundred and twenty-four eligible subjects will be randomly assigned 3:1 to receive DWP-450 or placebo. Safety and efficacy will be assessed on Days 2, 7, 14, 30, 90, 120 and 150. The primary efficacy end point assesses the effectiveness of the DWP-450 against placebo on Day 30 in a superiority design.

Conditions

Glabellar Frown Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Botulinum toxin, Type A

Botulinum toxin, Type A

Group Type: EXPERIMENTAL

Botulinum toxin, Type A

Intervention Type: BIOLOGICAL

Botulinum toxin, Type A

Placebo

0.9% sterile, unpreserved saline

Group Type: PLACEBO_COMPARATOR

0.9% sterile, unpreserved saline

Intervention Type: OTHER

Placebo Comparator Arm

Interventions

Botulinum toxin, Type A

Botulinum toxin, Type A

Intervention Type: BIOLOGICAL

0.9% sterile, unpreserved saline

Placebo Comparator Arm

Intervention Type: OTHER

Other Intervention Names

DWP-450 (Botulinum purified neurotoxin, Type A) Injection; DWP-450

Eligibility Criteria

Inclusion Criteria

• Subjects is an adult, of at least 18 years of age
• Subject is able to provide informed consent and comply with study instructions
• Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS
• Subject has moderate to severe glabellar lines at maximum frown as assessed by the 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)
• Subjects who may not 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Evolus, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Avelar, MD

Role: STUDY_DIRECTOR

Evolus, iInc.

Locations

The Clinical Testing Center of Beverly Hills

Beverly Hills, California, United States

Countries

United States

Other Identifiers

EV-002

Identifier Type: -

Identifier Source: org_study_id