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

Completed

Conditions studied: Facial Lipoatrophy

In brief

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.

Key facts

Study ID

NCT00360932

Run by

Bausch Health Americas, Inc.

People needed

290

Starts

2005-10-01

Expected to finish

2011-08-01

Last updated by the study team

2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects seropositive for human immunodeficiency virus;
• In the investigator's judgment, a high probability of 5 year survival and compliance with the study visit schedule;
• Initiating SCULPTRA treatments;
• Ability to comprehend and sign an informed consent document prior to study enrollment.
• No waiver, prospective or retrospective, to deviate in any way from the inclusion/exclusion criteria for clinical study subjects, defined in the study protocol, can be granted to clinical investigators.

You may not qualify if…

• Any active skin inflammation or infection in or near the treatment area;
• Any hypersensitivity to the components of SCULPTRA
• Previous treatment with SCULPTRA or any other product for facial lipoatrophy;
• Pregnancy or breastfeeding or anticipating becoming pregnant during the study period; and
• Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.
• No waiver, prospective or retrospective, to deviate in any way from the inclusion/exclusion criteria for clinical study subjects, defined in the study protocol, can be granted to clinical investigators.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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