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

NCT00360932 | Completed

• 1 other identifier: DL6049-0417
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Lipoatrophy

Keywords

facial lipoatrophy; HIV/AIDs

Outcome Measures

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.

  5 years

Secondary Outcomes (3)

• Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;

  5 years

• Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and

  5 years

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

  5 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tara Semanchek, MBA

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 7, 2006
• Study Start: October 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

US (1)