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

Glabellar Frown Lines Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303002
• Other study ID #: RT002-CL002
• Secondary ID: CTA Control No.
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2014
• Last updated: March 8, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Revance Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• Botulinum Toxin Type A
Intramuscular injection (IM)
• Active Comparator botulinum toxin
IM injection
• Placebo Comparator
IM injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revance Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown		Week 24	No
Primary	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	No