Crow's Feet, Facial Wrinkles, Lateral Canthal Lines
Conditions
Keywords
Lateral Canthal Lines, Crow's Feet Wrinkles, Facial Wrinkles
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.
Interventions
DRUGRT001 Botulinum toxin type A (Dose A)
RT001 Botulinum Toxin Type A (Dose A)
DRUGRT001 Botulinum Toxin Type A (Dose B)
RT001 Botulinum Toxin Type A (Dose B)
OTHERVehicle
Vehicle Control
DRUGPlacebo
Placebo Comparator
Sponsors
Revance Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject improvement based in investigator assessment | Week 4 | The number of subjects who show improvement based on the investigator global assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Improvement Based on investigator and patient assessments | Week 4 | The number of subjects who show improvement based on the investigator global and patient assessments |
Countries
United States
Outcome results
None listed