A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging

Bausch Health

Status: Completed

Conditions: Mid Facial Contour Deficiencies

Treatments: Device: DL6049 (injectable poly-L-lactic acid)

Study type: Observational

Funder types: Industry

Identifiers

NCT00487474

DL6049-0502

Details and patient eligibility

About

• 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Sculptra

Treatment:

Device: DL6049 (injectable poly-L-lactic acid)