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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: August 3, 2006
Last updated: October 28, 2011
Last verified: October 2011
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Further study details as provided by Sanofi:

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 ]

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 ]
  • 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 ]

Enrollment: 290
Study Start Date: October 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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.
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Please refer to this study by its identifier: NCT00360932

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: Tara Semanchek, MBA Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00360932     History of Changes
Other Study ID Numbers: DL6049-0417
Study First Received: August 3, 2006
Last Updated: October 28, 2011

Keywords provided by Sanofi:
facial lipoatrophy

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on May 24, 2017