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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00487474
First received: June 15, 2007
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose
  • 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

Condition Intervention Phase
Mid Facial Contour Deficiencies
 Device: DL6049 (injectable poly-L-lactic acid)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of Sculptra (Poly-L-Lactic Acid) Measured by Three Dimensional Digital Surface Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlate the mean volumetric change in mid-facial treatment area with the amount of product used. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Determine mean change from baseline in the contour deficiency score as determined by the investigator. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Investigator Global Assessment of Improvement - Excellent Improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Investigator Global Assessment of Improvement - Much Improved [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Investigator Global Assessment of Improvement - Improved [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Investigator Global Assessment of Improvement - No Change [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Investigator Global Assessment of Improvement - Worse [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Improvement - Excellent Improvement [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Improvement - Much Improved [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Improvement - Improved [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Improvement - No Change [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Improvement - Worse [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2007
Study Completion Date: February 2008
Arms Assigned Interventions
Experimental: Sculptra Device: DL6049 (injectable poly-L-lactic acid)
Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert
Other Name: Sculptra

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487474

Locations
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener, MT, ASCP Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00487474     History of Changes
Other Study ID Numbers: DL6049-0502
Study First Received: June 15, 2007
Last Updated: March 12, 2009
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on May 23, 2013