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Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)

NCT00360932 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2019-09-18

No results posted yet for this study

Summary

5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.

Conditions

  • Facial Lipoatrophy

Interventions

DEVICE

SCULPTRA (poly-L-lactic acid injection)

Subjects will be treated with SCULPTRA® according to the investigator's judgment, and in accordance with the SCULPTRA® package insert. Details of the exact amount and the time of administration of SCULPTRA® (date, amount, location) will be documented in the CRF at each protocol and non-protocol visit.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Tara Semanchek, MBA · Sanofi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

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 NCT00360932 on ClinicalTrials.gov