* Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging * Determine the mean change from baseline in facial contour deficiency as measured by the Dermik Nasolabial Photo-numeric Scale * Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale * Correlate the mean volumetric change in mid-facial treatment area with the amount of product used * Evaluate subject and investigator global assessment of improvement and subject treatment satisfaction at the end of treatment * Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment * Collect safety data
Study Type
OBSERVATIONAL
Enrollment
20
Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
Unnamed facility
London, United Kingdom
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
Time frame: 6 months
Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging
Time frame: 6 months
Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale.
Time frame: 6 months
Correlate the mean volumetric change in mid-facial treatment area with the amount of product used.
Time frame: 6 months
Determine mean change from baseline in the contour deficiency score as determined by the investigator.
Time frame: 6 months
Investigator Global Assessment of Improvement - Excellent Improvement
Time frame: 6 months
Investigator Global Assessment of Improvement - Much Improved
Time frame: 6 Months
Investigator Global Assessment of Improvement - Improved
Time frame: 6 Months
Investigator Global Assessment of Improvement - No Change
Time frame: 6 Months
Investigator Global Assessment of Improvement - Worse
Time frame: 6 Months
Subject Global Assessment of Improvement - Excellent Improvement
Time frame: 6 Months
Subject Global Assessment of Improvement - Much Improved
Time frame: 6 Months
Subject Global Assessment of Improvement - Improved
Time frame: 6 Months
Subject Global Assessment of Improvement - No Change
Time frame: 6 Months
Subject Global Assessment of Improvement - Worse
Time frame: 6 Months
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