Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet
1 other identifier
interventional
111
1 country
6
Brief Summary
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 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 P50-P75 for phase_2
Started May 2011
Shorter than P25 for phase_2
6 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
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 1, 2013
June 1, 2013
9 months
May 20, 2011
June 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy will be assessed by Investigator's Global Assessment Score
Wrinkle scale with definitions of severity
2 weeks
Secondary Outcomes (2)
Subject Self Assessment (SSA) scale
2 Weeks
Investigator Global Assessment scale
Week 1, 2, 4, 8, 12
Study Arms (6)
Placebo Comparator
PLACEBO COMPARATORDose 1
EXPERIMENTALDose 1
Dose 2
EXPERIMENTALDose 2
Dose 3
EXPERIMENTALDose 3
Dose 4
EXPERIMENTALDose 4
Dose 5
EXPERIMENTALDose 5
Interventions
The interventions differ by dose of investigational product applied.
The interventions differ by dose of investigational product applied.
Eligibility Criteria
You may qualify if:
- mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
- moderate to severe Crow's Feet (IGA 3-4) 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 (6)
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205, United States
Baumann Cosmetic & Research Institute
Miami Beach, Florida, 33140, United States
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, 33401, United States
William Coleman III, MD, APMC
Metairie, Louisiana, 70006, United States
Gramercy Park Dermatology
New York, New York, 10010, United States
Cary Skin Care
Cary, North Carolina, 27519, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 24, 2011
Study Start
May 1, 2011
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
July 1, 2013
Record last verified: 2013-06