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

Facial Lipoatrophy Clinical Trial

— FACES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360932
• Other study ID #: DL6049-0417
• Status: Completed
• Start date: October 2005
• Est. completion date: August 2011

Study information

• Verified date: September 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Lipoatrophy
• Facies
• Lipodystrophy

Intervention

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.

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and		5 years
Secondary	Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.		5 years