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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Facial Lipoatrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No