Trial | NCT00888914  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.
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 Started
Nov 30
2008
Primary Completion
Jan 31
2009
Study Completion
Feb 28
2009
Last Update
Nov 19
2013
Estimate

Drug RT001

RT001

Drug RT001

RT001

Drug RT001

RT001

Drug RT001

RT001

Other Vehicle Comparator

Vehicle Comparator

Dose A Active Comparator

RT001 Dose A; Active Comparator

Dose B Active Comparator

RT001 Dose B; Active Comparator

Dose C Active Comparator

RT001 Dose C; Active Comparator

Dose D Active Comparator

RT001 Dose D; Active Comparator

Dose E Placebo Comparator

RT001 Dose E; Vehicle Comparator

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
No Results Posted