Status:
COMPLETED
Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Facial Lipoatrophy
Eligibility:
All Genders
18+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00360932
Start Date
October 1 2005
End Date
August 1 2011
Last Update
September 18 2019
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807