Suspended
Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
What is being tested
Botulinum Toxin Type A
Drug
Who is being recruted
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: February 2013
Summary
Principal SponsorRevance Therapeutics, Inc.
Last updated: May 7, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.
Principal SponsorRevance Therapeutics, Inc.
Last updated: May 7, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
311 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Female or male, 18 years of age and above and in good general health
Moderate to severe crow's feet lines
Women of childbearing potential must agree to use an effective method of birth control during the course of the study
7 exclusion criteria prevent from participating
Active skin disease or irritation at the treatment area
Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
Chemical peel during the 9 months prior to treatment
Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDose A: Botulinum toxin type A
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Nashville Centre for Laser and Facial Surgery
Nashville, United StatesOpen Nashville Centre for Laser and Facial Surgery in Google MapsSuspendedOne Study Center