Dose Finding Study In Subjects With Crow's Feet
Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
1 other identifier
interventional
145
1 country
10
Brief Summary
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2013
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 22, 2013
CompletedFirst Posted
Study publicly available on registry
September 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMay 29, 2014
May 1, 2014
3 months
September 22, 2013
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigators Global Assessment Scale
Crow's Feet Wrinkle Scale
Week 4
Secondary Outcomes (1)
Subject Self-Assessment score
up to 12 12 weeks
Study Arms (6)
Vehicle
PLACEBO COMPARATORvehicle without ANT-1401
Dose 1
EXPERIMENTALlowest dose
Dose 2
EXPERIMENTALsecond lowest dose
Dose 3
EXPERIMENTALmid-level dose
Dose 4
EXPERIMENTALsecond highest dose
Dose 5
EXPERIMENTALhighest dose
Interventions
Eligibility Criteria
You may qualify if:
- years of age
- mild to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet wrinkles on contraction
- willingness to refrain from any product affecting skin remodeling
- female subjects must be not pregnant and non-lactating
You may not qualify if:
- history of peri-ocular surgery, brow lift or related procedures
- procedures affecting the lateral canthal region in the prior 12 months
- application of topical prescription medication to the treatment area
- female subjects who are pregnant or are nursing a child
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anterios Inc.lead
Study Sites (10)
Unknown Facility
Miami, Florida, 33137, United States
Unknown Facility
Pinellas Park, Florida, 33781, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
New Orleans, Louisiana, 70124, United States
Unknown Facility
Rochester, New York, 14623, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Knoxville, Tennessee, 37922, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2013
First Posted
September 27, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
May 29, 2014
Record last verified: 2014-05