Clinical trial NCT00907387: Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Keywords: Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: San Francisco
country: United States
facility: Richard G. Glogau, Inc.
state: California
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
city: Chestnut Hill
country: United States
facility: SkinCare Physicians, Inc.
state: Massachusetts
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: New York City
country: United States
facility: Head and Neck Surgical Group
state: New York
city: New York City
country: United States
facility: Aesthetic Plastic Surgery
state: New York
city: White Plains
country: United States
facility: Dermatology Surgery and Laser Center
state: New York
city: Houston
country: United States
facility: Suzanne Bruce & Associates / The Center for Skin Research
state: Texas
Study officials:
affiliation: Revance Therapeutics, Inc.
name: Debbie Tranowski
role: STUDY_DIRECTOR
References: