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

August 3, 2006
October 28, 2011
October 2005
August 2011   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00360932 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;
  • Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and
  • Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Facial Lipoatrophy
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360932
DL6049-0417
No
Sanofi
Sanofi
Not Provided
Study Director: Tara Semanchek, MBA Sanofi
Sanofi
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP