NCT00487474

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	DL6049 (injectable poly-L-lactic acid)	Subjects will be treated with SCULPTRA® every 4-6 weeks in accordance with SCULPTRA® package insert

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-06-18
• Last updated: 2019-09-18

Locations

1 site across 1 country: United Kingdom