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Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907387
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 22, 2009
Last Update Posted Date January 17, 2014
Study Start Date  ICMJE April 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2010)
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28 [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28; incidence of treatment emergent AEs [ Time Frame: Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2010)
Incidence of treatment-emergent adverse events [ Time Frame: Day 28 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Official Title  ICMJE A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment Lateral Canthal Lines in Adults
Brief Summary The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.
Detailed Description

This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.

At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lateral Canthal Lines
Intervention  ICMJE
  • Drug: RT001
    Dose A RT001
  • Drug: RT001
    Dose B RT001
  • Other: Placebo
    Dose C Placebo
Study Arms  ICMJE
  • Active Comparator: Dose A
    Dose A RT001
    Intervention: Drug: RT001
  • Active Comparator: Dose B
    Dose B RT001
    Intervention: Drug: RT001
  • Placebo Comparator: Dose C
    Dose C Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2010)
72
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
180
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female or male, 30 to 60 years of age
  • Bilateral lateral canthal lines rated as moderate or severe
  • Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and through End of Study
  • Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study

Exclusion Criteria:

  • Muscle weakness or paralysis in the area receiving study treatment -Active skin disease or irritation at the treatment areas
  • Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening
  • Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28)
  • Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure.
  • Previous treatment with Botulinum Toxin Type A in the face area
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907387
Other Study ID Numbers  ICMJE RT001-CL010LCL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Revance Therapeutics, Inc.
Study Sponsor  ICMJE Revance Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Debbie Tranowski Revance Therapeutics, Inc.
PRS Account Revance Therapeutics, Inc.
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP