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

Bausch Health Americas, Inc.290 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

290

Conditions

Facial Lipoatrophy

Interventions

SCULPTRA (poly-L-lactic acid injection)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;

Time frame: 5 years

Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and

Time frame: 5 years

Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.

Time frame: 5 years

Data from ClinicalTrials.gov

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