A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

December 24, 2013 updated by: Revance Therapeutics, Inc.

A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Study Type

Interventional

Enrollment (Actual)

180

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, LLC

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:

  • Written informed consent including authorization to release health information
  • Female or male, 18 to 65 years of age and in good general health
  • Willing and able to follow study instructions and likely to complete all study requirements
  • Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

  • Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active disease or irritation at the treatment areas including the eye and the skin
  • Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
  • Previous participation in a RT001 clinical study

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: RT001 Botulinum toxin Type A (Dose A)
RT001 (Botulinum toxin Type A)
Drug: RT001 Botulinum toxin type A (Dose A)
RT001 Botulinum Toxin Type A (Dose A)
Experimental: RT001 Botulinum toxin type A (Dose B)
RT001 (Botulinum Toxin Type A)
Drug: RT001 Botulinum Toxin Type A (Dose B)
RT001 Botulinum Toxin Type A (Dose B)
Other: Dose C
Vehicle Control
Other: Vehicle
Vehicle Control
Placebo Comparator: Dose D
Placebo
Drug: Placebo
Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject improvement based in investigator assessment
Time Frame: Week 4
The number of subjects who show improvement based on the investigator global assessment
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Improvement Based on investigator and patient assessments
Time Frame: Week 4
The number of subjects who show improvement based on the investigator global and patient assessments
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

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT001-CL017LCL

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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