Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines (REALISE 1)

September 7, 2016 updated by: Revance Therapeutics, Inc.
This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

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

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In good general health
  • Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
  • Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

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 area receiving study treatment
  • Active skin disease or irritation or disrupted barrier at the treatment area
  • Active eye disease or irritation
  • Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
  • Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
  • Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
  • Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else 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
Experimental: Dose A
Botulinum toxin type A
Biological: Botulinum toxin type A
Topical botulinum toxin type A
Placebo Comparator: Dose B
Placebo comparator
Biological: Placebo comparator
Topical placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
Time Frame: Week 4
Week 4

Secondary Outcome Measures

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

September 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT001-CL038

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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