Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333684
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2006-06-02
Brief Title:
Safety Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
Sponsor:
Canadian Immunodeficiency Research Collaborative
Organization:
Canadian Immunodeficiency Research Collaborative
Study Overview
Official Title:
A Prospective Study Evaluating the Safety Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid Soft Tissue Endoprosthesis
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate and record any changes in the Quality of Life and psychological state of the affected study group following treatment with Bio-Alcamid
Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy Pre-treatment classification and post treatment recording of changes will be performed by both the Principal Investigator and the Treatment Specialist and independently by a Blinded Co-Investigator at post treatment Week 12
Safety data for Bio-Alcamid will be collected throughout the duration of the study Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid
Evaluate the safety and efficacy of Bio-Alcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy Pre-treatment classification and post treatment recording of changes will be performed by both the Principal Investigator and the Treatment Specialist and independently by a Blinded Co-Investigator at post treatment Week 12
Safety data for Bio-Alcamid will be collected throughout the duration of the study Safety will be determined by the rates of procedure-related events and adverse experiences associated with the use of Bio-Alcamid
Detailed Description:
Thirty 30 participants in the randomized portion of the study will be selected who have been classified as having moderate to severe facial lipoatrophy based on the three investigators evaluations
These patients will be divided into two groups -
The Treatment Group - 15 At Day -1 the Treatment group will be established by the inclusionexclusion criteria and consent forms will be signed At Day 0 they will complete QOL Surveys and will receive treatment with Bio-Alcamid in the affected facial areas At Day 7 they will return to complete the QOL Surveys and allow the CITS to determine if a touch-up is necessary If so one touch-up session is permitted at week 6 The participants will again complete QOL Surveys and have efficacy assessments at week 12 The Treatment Group will continue with follow-up sessions at week 24 48 60 and at 96 weeks Professional clinical photographs will be taken at each visit
The Control Group - 15 At Day -1 the Control group will be established by the inclusionexclusion criteria and consent forms will be signed At Day 0 they will complete QOL Surveys They will return for visits at baseline and week 6 as well to complete QOL Surveys At Week 12 they will complete the QOL Surveys and will receive a BA treatment At Week 13 they will return to complete the QOL Surveys and allow the CITS to determine if a touch-up is necessary If so one touch-up session is permitted at week 18 If not these participants will again complete QOL Surveys and have efficacy assessments at week 24 The Control Group will continue with follow-up sessions at week 48 60 96 and at 104 weeks Professional clinical photographs will be taken at each visit
These patients will be divided into two groups -
The Treatment Group - 15 At Day -1 the Treatment group will be established by the inclusionexclusion criteria and consent forms will be signed At Day 0 they will complete QOL Surveys and will receive treatment with Bio-Alcamid in the affected facial areas At Day 7 they will return to complete the QOL Surveys and allow the CITS to determine if a touch-up is necessary If so one touch-up session is permitted at week 6 The participants will again complete QOL Surveys and have efficacy assessments at week 12 The Treatment Group will continue with follow-up sessions at week 24 48 60 and at 96 weeks Professional clinical photographs will be taken at each visit
The Control Group - 15 At Day -1 the Control group will be established by the inclusionexclusion criteria and consent forms will be signed At Day 0 they will complete QOL Surveys They will return for visits at baseline and week 6 as well to complete QOL Surveys At Week 12 they will complete the QOL Surveys and will receive a BA treatment At Week 13 they will return to complete the QOL Surveys and allow the CITS to determine if a touch-up is necessary If so one touch-up session is permitted at week 18 If not these participants will again complete QOL Surveys and have efficacy assessments at week 24 The Control Group will continue with follow-up sessions at week 48 60 96 and at 104 weeks Professional clinical photographs will be taken at each visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None