Clinical trial NCT00360932: Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
Official title: An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Lipoatrophy
Keywords: facial lipoatrophy
HIV/AIDs
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-07
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects seropositive for human immunodeficiency virus who in the investigator's judgment, have a high probability of 5 year survival and compliance with the study visit schedule, and are initiating SCULPTRA treatments.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;
timeFrame: 5 years
measure: Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and
timeFrame: 5 years
measure: Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.
timeFrame: 5 years
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Tara Semanchek, MBA
role: STUDY_DIRECTOR
References: