Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
United States290 participantsStarted 2005-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
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.