Facial Lipoatrophy Correction Experience With SCULPTRA (FACES Study)

Study Overview
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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.

Official Title
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An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)

Conditions
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Facial Lipoatrophy

Intervention / Treatment
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* Device: SCULPTRA (poly-L-lactic acid injection)


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate, by Fitzpatrick skin type and by gender, long-term safety of Poly-L-Lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment; |  | 5 years | 
| Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and |  | 5 years | 
| Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial lipoatrophy, HIV/AIDs