Clinical trial NCT00487474: A Single-Center, Open-Label, Exploratory Study of the Volumizing Effect of SCULPTRA Measured by Three Dimensional Digital Surface Imaging
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mid Facial Contour Deficiencies
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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.

Primary outcomes:
measure: Measure the mid-facial volumetric correction from SCULPTRA treatment, using three-dimensional digital surface imaging.
timeFrame: 6 months
Secondary outcomes:
measure: Determine the mean change from baseline in Nasolabial volume as measured by 3-D digital surface imaging
timeFrame: 6 months
measure: Correlate volumetric correction with clinical improvement as measured by the Dermik Nasolabial Photo-numeric Scale.
timeFrame: 6 months
measure: Correlate the mean volumetric change in mid-facial treatment area with the amount of product used.
timeFrame: 6 months
measure: Determine mean change from baseline in the contour deficiency score as determined by the investigator.
timeFrame: 6 months
measure: Investigator Global Assessment of Improvement - Excellent Improvement
timeFrame: 6 months
measure: Investigator Global Assessment of Improvement - Much Improved
timeFrame: 6 Months
measure: Investigator Global Assessment of Improvement - Improved
timeFrame: 6 Months
measure: Investigator Global Assessment of Improvement - No Change
timeFrame: 6 Months
measure: Investigator Global Assessment of Improvement - Worse
timeFrame: 6 Months
measure: Subject Global Assessment of Improvement - Excellent Improvement
timeFrame: 6 Months
measure: Subject Global Assessment of Improvement - Much Improved
timeFrame: 6 Months
measure: Subject Global Assessment of Improvement - Improved
timeFrame: 6 Months
measure: Subject Global Assessment of Improvement - No Change
timeFrame: 6 Months
measure: Subject Global Assessment of Improvement - Worse
timeFrame: 6 Months
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: Sanofi
name: Phyllis Diener, MT, ASCP
role: STUDY_DIRECTOR
References: