Mid Facial Contour Deficiencies
Conditions
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
Interventions
Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
Sponsors
Bausch Health Americas, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging | 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 |
| Investigator Global Assessment of Improvement - No Change | 6 Months |
Countries
United Kingdom
Outcome results
None listed