| August 3, 2006 |
| October 28, 2009 |
| November 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.
|
| |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Facial Lipoatrophy |
| Device: SCULPTRA (poly-L-lactic acid injection) |
| |
| |
| |
| Active, not recruiting |
| 300 |
| 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 |
| Study Director, sanofi-aventis |
| DL6049-0417 |
| Sanofi-Aventis |
|
| Study Director: |
Tara Semanchek, MBA |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| October 2009 |
