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Completed

NCT Number: NCT00360932

Facial Lipoatrophy Correction Experience With SCULPTRA ("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.

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Key information

Conditions

Facial Lipoatrophy Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCULPTRA (poly-L-lactic acid injection)

Device

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.

Primary outcomes

  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.

    Time frame: 5 years

Secondary outcomes

  1. 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

  2. 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

  3. Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES Study)

Acronym: FACES

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Aug 7, 2006
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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