NCT00487474|Completed
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Sponsor study identifier
observational
20
1 country
1
Study Start
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 15, 2007
Actual (reported)June 18, 2007
Actual (reported)February 2008
Actual (reported)February 2008
Actual (reported)Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
6 months
Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging
6 months
Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale.
6 months
Correlate the mean volumetric change in mid-facial treatment area with the amount of product used.
6 months
Determine mean change from baseline in the contour deficiency score as determined by the investigator.
6 months
Investigator Global Assessment of Improvement - Excellent Improvement
6 months
Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects with signs of facial contour deficiencies in the area of the nasolabial folds \[nasolabial fold scores greater than or equal to 2 (bilaterally) on the Dermik Nasolabial Photo-numeric Scale.
London, United Kingdom
Phyllis Diener, MT, ASCP
Sanofi
20 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2007
First Posted
June 18, 2007
Study Start
June 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
September 18, 2019
Record last verified: 2019-09
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Source: ClinicalTrials.gov.
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