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

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ClinicalTrials.gov Identifier: NCT00888914
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : November 19, 2013
Sponsor:
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.

Condition or disease Intervention/treatment Phase
Lateral Canthal Lines Crow's Feet Facial Wrinkles Drug: RT001 Other: Vehicle Comparator Phase 2

Detailed Description:
This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 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, to Treat Moderate to Severe Lateral Canthal Lines in Adults.
Study Start Date : November 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Active Comparator: Dose A
RT001 Dose A; Active Comparator
Drug: RT001
RT001
Active Comparator: Dose B
RT001 Dose B; Active Comparator
Drug: RT001
RT001
Active Comparator: Dose C
RT001 Dose C; Active Comparator
Drug: RT001
RT001
Active Comparator: Dose D
RT001 Dose D; Active Comparator
Drug: RT001
RT001
Placebo Comparator: Dose E
RT001 Dose E; Vehicle Comparator
Other: Vehicle Comparator
Vehicle Comparator



Primary Outcome Measures :
  1. The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28) [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28) [ Time Frame: Day 28 ]
  2. Incidence of treatment-emergent AEs [ Time Frame: Day 28 ]


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male; 30 to 55 years of age
  • Bilateral lateral canthal lines rated as moderate or advanced
  • Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening 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
  • Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0)
  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00888914


Locations
United States, California
Richard G. Glogau, MD
San Francisco, California, United States, 94117
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
Sponsors and Collaborators
Revance Therapeutics, Inc.

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00888914     History of Changes
Other Study ID Numbers: RT001-CL006LCL
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: October 2013

Keywords provided by Revance Therapeutics, Inc.:
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles