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

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines; Facial Wrinkles; Crow's Feet

Treatments: Other: Vehicle Comparator; Drug: RT001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00888914

RT001-CL006LCL

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

Dose A

Active Comparator group

Description:

RT001 Dose A; Active Comparator

Treatment:

Drug: RT001

Drug: RT001

Drug: RT001

Drug: RT001

Dose B

Active Comparator group

Description:

RT001 Dose B; Active Comparator

Treatment:

Drug: RT001

Drug: RT001

Drug: RT001

Drug: RT001

Dose C

Active Comparator group

Description:

RT001 Dose C; Active Comparator

Treatment:

Drug: RT001

Drug: RT001

Drug: RT001

Drug: RT001

Dose D

Active Comparator group

Description:

RT001 Dose D; Active Comparator

Treatment:

Drug: RT001

Drug: RT001

Drug: RT001

Drug: RT001

Dose E

Placebo Comparator group

Description:

RT001 Dose E; Vehicle Comparator

Treatment:

Other: Vehicle Comparator