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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00360932
First received: August 3, 2006
Last updated: October 28, 2011
Last verified: October 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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 ]

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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Tara Semanchek, MBA Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00360932     History of Changes
Other Study ID Numbers: DL6049-0417
Study First Received: August 3, 2006
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
facial lipoatrophy
HIV/AIDs

Additional relevant MeSH terms:
Facies
Lipodystrophy
Disease Attributes
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Skin Diseases
Skin Diseases, Metabolic

ClinicalTrials.gov processed this record on November 20, 2014