A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging
Completed
- Conditions
- Mid Facial Contour Deficiencies
- Interventions
- Device: DL6049 (injectable poly-L-lactic acid)
- Registration Number
- NCT00487474
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Subjects must sign a statement of informed consent.
- Subjects must be 18-75 years of age, of any race or gender.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to the first treatment with the product and must use an acceptable form of birth control throughout the study (e.g., oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study).
- Subjects must display 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.
- Subjects must be a suitable candidate for SCULPTRA treatment.
- Subjects must be able to understand the requirements of the study and be willing to comply with the study requirements
Exclusion Criteria
- Subjects with an allergy to any of the constituents of the product.
- Subjects with a known history of keloids or bleeding disorders.
- Subjects of childbearing potential who are pregnant, or plan to become pregnant within the study timeframe, or who are nursing.
- Subjects with significant facial hair (e.g. mustaches, beards, etc.)
- Subjects with an active inflammatory process or infection in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease in the treatment area).
- Subjects who plan to undergo major facial surgery [e.g., rhinoplasty (with or without implant), facelift, congenital defect repair, etc.] during the course of the study.
- Subjects who have used or plan to use exclusionary medications/treatments.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sculptra DL6049 (injectable poly-L-lactic acid) -
- Primary Outcome Measures
Name Time Method Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. 6 months
- Secondary Outcome Measures
Name Time Method 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 Investigator Global Assessment of Improvement - Much Improved 6 Months Investigator Global Assessment of Improvement - Improved 6 Months Investigator Global Assessment of Improvement - No Change 6 Months Investigator Global Assessment of Improvement - Worse 6 Months Subject Global Assessment of Improvement - Excellent Improvement 6 Months Subject Global Assessment of Improvement - Much Improved 6 Months Subject Global Assessment of Improvement - Improved 6 Months Subject Global Assessment of Improvement - No Change 6 Months Subject Global Assessment of Improvement - Worse 6 Months