A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Revance Therapeutics, Inc.
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Subject improvement based in investigator assessment
Study Overview
Brief Summary
The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.
Detailed Description
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Written informed consent including authorization to release health information
- •Female or male, 18 to 65 years of age and in good general health
- •Willing and able to follow study instructions and likely to complete all study requirements
- •Moderate to severe lateral canthal lines (crow's feet wrinkles)
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 such as Lambert-Eaton syndrome and myasthenia gravis
- •Muscle weakness or paralysis, particularly in the area receiving study treatment
- •Active disease or irritation at the treatment areas including the eye and the skin
- •Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
- •Previous participation in a RT001 clinical study
Arms & Interventions
RT001 Botulinum toxin Type A (Dose A)
RT001 (Botulinum toxin Type A)
Intervention: RT001 Botulinum toxin type A (Dose A) (Drug)
RT001 Botulinum toxin type A (Dose B)
RT001 (Botulinum Toxin Type A)
Intervention: RT001 Botulinum Toxin Type A (Dose B) (Drug)
Dose C
Vehicle Control
Intervention: Vehicle (Other)
Dose D
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Subject improvement based in investigator assessment
Time Frame: Week 4
The number of subjects who show improvement based on the investigator global assessment
Secondary Outcomes
- Subject Improvement Based on investigator and patient assessments(Week 4)