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

NCT00487474 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-09-18

No results posted yet for this study

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

DEVICE

DL6049 (injectable poly-L-lactic acid)

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

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Phyllis Diener, MT, ASCP · Sanofi

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487474 on ClinicalTrials.gov