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

Bausch Health

Status: Completed

Conditions: Facial Lipoatrophy

Treatments: Device: SCULPTRA (poly-L-lactic acid injection)

Study type: Observational

Funder types: Industry

Identifiers

NCT00360932

DL6049-0417

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA:

• 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.

EXCLUSION CRITERIA

• 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.