Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: Placebo Comparator; Biological: Botulinum Toxin Type A; Biological: Active Comparator botulinum toxin

• Registration Number: NCT02303002
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Moderate or severe glabellar frown lines
• Female or male, 30 to 65 years of age in good general health
• Women of childbearing potential must agree to use an effective method of birth control during the course of the study
• Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

Exclusion Criteria

• Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
• Muscle weakness or paralysis, particularly in the treatment area
• Active skin disease or infections or irritation at the treatment area
• Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
• Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose E	Placebo Comparator	Dose E: Placebo
Dose A	Botulinum Toxin Type A	Dose A: Botulinum Toxin Type A
Dose D	Active Comparator botulinum toxin	Dose D: Botulinum Toxin Type A
Dose B	Botulinum Toxin Type A	Dose B: Botulinum Toxin Type A
Dose C	Botulinum Toxin Type A	Dose C: Botulinum Toxin Type A

Primary Outcome Measures

Name	Time	Method
Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown	Week 24
Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity	Up to Week 36