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

Phase 2

Completed

• Conditions: Crow's Feet; Lateral Canthal Lines; Facial Wrinkles
• Interventions: Drug: Placebo; Drug: Botulinum Toxin Type A

• Registration Number: NCT00968942
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

Detailed Description

This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Disposition First Submitted: 2011-06-13
• Disposition First Submitted QC: 2011-06-13
• Disposition First Posted: 2011-06-27
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders
• Muscle weakness or paralysis in the area receiving study treatment
• Active skin disease or irritation at the treatment areas
• Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart
• Use of prescription retinoid products during the past 3 months prior to Screening
• Chemical peel (medium depth or deeper) during the past 9 months prior to Screening
• Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow lift or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening
• Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT
• Previous treatment with Botulinum Toxin Type A in the face area
• Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening
• Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at 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
• Clinically significant laboratory values at Screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose B	Placebo	Placebo
Dose A	Botulinum Toxin Type A	RT001

Primary Outcome Measures

Name	Time	Method
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs	Week 8

Secondary Outcome Measures

Name	Time	Method
The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Smile and at Rest from Baseline to Weeks 2, 4, 6, 8; incidence of treatment emergent AEs	Weeks 2, 4, 6, 8

Trial Locations

Locations (1)

Dermatology Research Institute, LLC.; 🇺🇸 Coral Gables, Florida, United States