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

NCT ID: NCT00487474

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-02-29

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sculptra

DL6049 (injectable poly-L-lactic acid)

Intervention Type: DEVICE

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

Interventions

DL6049 (injectable poly-L-lactic acid)

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

Intervention Type: DEVICE

Other Intervention Names

Sculptra

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phyllis Diener, MT, ASCP

Role: STUDY_DIRECTOR

Sanofi

Locations

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

DL6049-0502

Identifier Type: -

Identifier Source: org_study_id