Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study) (FACES)

September 14, 2019 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects seropositive for human immunodeficiency virus who in the investigator's judgment, have a high probability of 5 year survival and compliance with the study visit schedule, and are initiating SCULPTRA treatments.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years
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
5 years
Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Investigators

  • Study Director: Tara Semanchek, MBA, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 4, 2006

First Posted (ESTIMATE)

August 7, 2006

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 14, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DL6049-0417

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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