Facial Lipoatrophy Correction Experience With SCULPTRA (FACES Study)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00360932

Acronym

FACES

Enrollment

290

Registered

2006-08-07

Start date

2005-10-31

Completion date

2011-08-31

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Lipoatrophy

Keywords

facial lipoatrophy, HIV/AIDs

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.

Interventions

DEVICESCULPTRA (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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026