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

Completed

• Conditions: Facial Lipoatrophy

• Registration Number: NCT00360932
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-04
• Study First Posted: 2006-08-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-14
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.	5 years
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States