A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001

NCT02334423 | Completed Phase 3 Results

• 1 other identifier: EV-001
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject

  The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.

  Day 30

Secondary Outcomes (3)

• Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject

  Day 120

• Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject

  Day 150

• Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject

  Day 90

Study Arms (2)

Botulinum toxin, Type A

EXPERIMENTAL

Botulinum toxin, Type A

Biological: Botulinum toxin, Type A

Placebo

PLACEBO COMPARATOR

0.9 % sterile, unpreserved saline

Other: 0.9% sterile, unpreserved saline

Interventions

Botulinum toxin, Type A BIOLOGICAL

Botulinum toxin, Type A

Also known as: DWP-450, DWP-450 (Botulinum purified neurotoxin, Type A) Injection

Botulinum toxin, Type A

0.9% sterile, unpreserved saline OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evolus, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (1)

Steven Fagien, MD

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; DWP450; Injections

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Rui L. Avelar, MD
• Organization: Evolus, Inc

rui@evolusinc.com

(805)689-8668

Study Officials

• Rui Avelar, MD

  Evolus, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 27, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-03

Locations

US (1)