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

A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of Sculptra (Poly-L-lactic Acid) Measured by Three Dimensional Digital Surface Imaging

• 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

Study Overview

• Status: Completed
• Conditions: Mid Facial Contour Deficiencies
• Intervention / Treatment: Device: DL6049 (injectable poly-L-lactic acid)

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Sculptra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Investigator Global Assessment of Improvement - Much Improved	6 Months
Investigator Global Assessment of Improvement - Improved	6 Months
Investigator Global Assessment of Improvement - No Change	6 Months
Investigator Global Assessment of Improvement - Worse	6 Months
Subject Global Assessment of Improvement - Excellent Improvement	6 Months
Subject Global Assessment of Improvement - Much Improved	6 Months
Subject Global Assessment of Improvement - Improved	6 Months
Subject Global Assessment of Improvement - No Change	6 Months
Subject Global Assessment of Improvement - Worse	6 Months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Phyllis Diener, MT, ASCP, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 15, 2007
• First Submitted That Met QC Criteria: June 15, 2007
• First Posted (Estimate): June 18, 2007

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 14, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: DL6049-0502