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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00888914
First received: April 24, 2009
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Drug: RT001
Other: Vehicle Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Revance Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent AEs [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888914

Locations
United States, California
Richard G. Glogau, MD
San Francisco, California, United States, 94117
United States, New York
Aesthetic Plastic Surgery
New York City, New York, United States, 10065
Head and Neck Surgical Group
New York City, New York, United States, 10019
Dermatology Surgery and Laser Center
White Plains, New York, United States, 10604
Sponsors and Collaborators
Revance Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00888914     History of Changes
Other Study ID Numbers: RT001-CL006LCL
Study First Received: April 24, 2009
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014