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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. Identifier: NCT00907387
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Drug: RT001 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Active Comparator: Dose A
Dose A RT001
Drug: RT001
Dose A RT001

Active Comparator: Dose B
Dose B RT001
Drug: RT001
Dose B RT001

Placebo Comparator: Dose C
Dose C Placebo
Other: Placebo
Dose C Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Day 28 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907387

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United States, Alabama
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
United States, California
Richard G. Glogau, Inc.
San Francisco, California, United States, 94117
United States, Florida
Dermatology Research Institute, LLC
Coral Gables, Florida, United States, 33146
United States, Massachusetts
SkinCare Physicians, Inc.
Chestnut Hill, Massachusetts, United States, 02467
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New York
Head and Neck Surgical Group
New York City, New York, United States, 10019
Aesthetic Plastic Surgery
New York City, New York, United States, 10065
Dermatology Surgery and Laser Center
White Plains, New York, United States, 10604
United States, Texas
Suzanne Bruce & Associates / The Center for Skin Research
Houston, Texas, United States, 77056
Sponsors and Collaborators
Revance Therapeutics, Inc.
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Study Director: Debbie Tranowski Revance Therapeutics, Inc.
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Responsible Party: Revance Therapeutics, Inc. Identifier: NCT00907387    
Other Study ID Numbers: RT001-CL010LCL
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: December 2013
Keywords provided by Revance Therapeutics, Inc.:
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles