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

NCT00487474 | Completed

• 1 other identifier: DL6049-0502
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Mid Facial Contour Deficiencies

Outcome Measures

Primary Outcomes (1)

• Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.

  6 months

Secondary Outcomes (14)

• 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

Study Arms (1)

Sculptra

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

Interventions

DL6049 (injectable poly-L-lactic acid) DEVICE

Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert

Also known as: Sculptra

Sculptra

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

Study Officials

• Phyllis Diener, MT, ASCP

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

GB (1)