- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01818076
Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
April 14, 2014 updated by: Revance Therapeutics, Inc.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
311
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Nashville Centre for Laser and Facial Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Moderate to severe crow's feet lines
- Female or male, 18 years of age and above and in good general health
- Women of childbearing potential must agree 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
- Muscle weakness or paralysis, particularly in the area receiving study treatment
- Active skin disease or irritation at the treatment area
- Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
- Treatment with botulinum toxin type A for crow's feet lines in the last 3 months
- Chemical peel during the 9 months prior to treatment
- Use of prescription retinoid products during the 3 months prior to treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose A
Dose A: Botulinum toxin type A
|
Botulinum toxin type A, Dose A applied to the lateral canthal area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
Time Frame: Up to 24 months
|
Up to 24 months
|
Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments
Time Frame: Up to 24 months
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 20, 2013
First Submitted That Met QC Criteria
March 21, 2013
First Posted (Estimate)
March 26, 2013
Study Record Updates
Last Update Posted (Estimate)
May 7, 2014
Last Update Submitted That Met QC Criteria
April 14, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT001-CL023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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