Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

December 27, 2013 updated by: Revance Therapeutics, Inc.
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

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

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Dermatology Research Institute

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe crow's feet lines
  • Female or male, 18 to 65 years of age and in good general health
  • Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

  • Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active skin disease or irritation at the treatment area
  • Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
  • Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Dose B
Dose B: Placebo
Drug: Placebo
Placebo, Dose B; dose applied to the lateral canthal lines
Experimental: Dose A
Dose A: Botulinum Toxin Type A
Drug: Botulinum Toxin Type A
Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint
Time Frame: Week 4
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment with 2 points or greater improvement from baseline
Time Frame: Week 4
Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment
Week 4
Investigator Global Assessment with 1 point or greater improvement from baseline
Time Frame: Week 4
Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment
Week 4
Patient Severity Assessment with 2 points or greater improvement from baseline
Time Frame: Week 4
Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment
Week 4

Collaborators and Investigators

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

Sponsor

Revance Therapeutics, Inc.

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

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

December 27, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT001-CL035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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