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

March 8, 2016 updated by: Revance Therapeutics, Inc.
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose A
Dose A: Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
Intramuscular injection (IM)
Experimental: Dose B
Dose B: Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
Intramuscular injection (IM)
Experimental: Dose C
Dose C: Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
Intramuscular injection (IM)
Active Comparator: Dose D
Dose D: Botulinum Toxin Type A
Biological: Active Comparator botulinum toxin
IM injection
Placebo Comparator: Dose E
Dose E: Placebo
Biological: Placebo Comparator
IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
Time Frame: Week 24
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
Time Frame: Up to Week 36
Up to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revance Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT002-CL002
  • CTA Control No. 179120 (Other Identifier: Health Canada)
  • File No. 9427-R1312\1-22C (Other Identifier: Health Canada)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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