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

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ClinicalTrials.gov Identifier: NCT00487474
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:

Study Description
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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging. [ Time Frame: 6 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487474


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

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00487474     History of Changes
Other Study ID Numbers: DL6049-0502
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs