Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00360932

Purpose

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.

Condition	Intervention	Phase
Facial Lipoatrophy	Device: SCULPTRA (poly-L-lactic acid injection)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Lactic acid Poly-L-lactic acid

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	November 2005
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360932

Locations

United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Tara Semanchek, MBA

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	DL6049-0417
Study First Received:	August 3, 2006
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00360932 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

facial lipoatrophy
HIV/AIDs

Additional relevant MeSH terms:

Disease Attributes
Metabolic Diseases
Pathologic Processes
Skin Diseases

Facies
Skin Diseases, Metabolic
Lipodystrophy
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009