Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00360932
First received: August 3, 2006
Last updated: October 28, 2011
Last verified: October 2011
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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.
![](https://webarchive.library.unt.edu/web/20130309095908im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
![](https://webarchive.library.unt.edu/web/20130309095908im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130309095908im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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:
Acquired Immunodeficiency Syndrome HIV Infections Facies Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Disease Attributes Pathologic Processes Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 07, 2013