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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 January 2013 |
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Main ID: |
NCT01358695 |
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Date of registration:
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20/05/2011 |
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Primary sponsor: |
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Public title:
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Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet
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Scientific title:
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Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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111 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01358695 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crow's Feet
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Lateral Canthal Lines
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Intervention(s)
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Biological: ANT-1207
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Biological: Botulinum Toxin Type A
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Biological: Botulinum Toxin, Type A
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Primary Outcome(s)
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Efficacy will be assessed by Investigator's Global Assessment Score
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Investigator Global Assessment scale
[Time Frame: Week 1, 2, 4, 8, 12]
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Subject Self Assessment (SSA) scale
[Time Frame: 2 Weeks]
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Secondary ID(s)
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ANT-1207-201-LCL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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