Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus Facial Lipoatrophy |
Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]To evaluate Quality of Life using the slightly modified Dermatology Quality Life Survey and the MOS-HIV Survey.
- Evaluate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]valuate the safety and efficacy of Bioalcamid for restoring the natural fullness and contours of the face affected by HIV drug-induced lipoatrophy.
| Enrollment: | 36 |
| Study Start Date: | December 2004 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: receive bioalcamid at baseline
half subjects received bioalcamid at baseline
|
Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
|
|
Active Comparator: Receive bioalcamid at 24 weeks
other half of subjets received bioalcamid at 24 weeks
|
Device: BIO-ALCAMID SOFT TISSUE ENDOPROSTHESIS
prosthetic bioalcamid was injected- amounts determined by the plastic surgeon and depended individual needs
|
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 inclusion/exclusion 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 area(s). 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 inclusion/exclusion 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have moderate to severe levels of facial lipoatrophy determined by the three investigstors
- If female of child-bearing potential (not menopausal for at least 1 year nor surgically sterile), have a negative urine pregnancy test prior to any study treatments and be willing to use oral contraception or another medically acceptable form of contraception for the duration of the study
- Be able to understand and comply with the requirements of this study
- Be willing and able to provide written Informed Consent prior to any study-related procedures being performed
- Agree to refrain from seeking other treatment for lipoatrophy in the facial area while participating in this study
Exclusion Criteria:
- Are pregnant, lactating, or trying to become pregnant
- Had prior therapy (e.g., other permanent or biodegradable injectable fillers or surgical correction such as a face-lift, etc.) within 9 months prior to entry into the study or are planning to undergo such therapy during the study
- Have any active inflammation, infection, or unhealed wound of the face
- Have any contraindicated condition described in the package insert for the product to be administered.
- Have a history of anaphylaxis or multiple severe allergies.
- Have planned relocation during the study, which would make follow-up visits impossible during the course of the study
- Used aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to initial or touch-up treatment or are taking concomitant anticoagulant therapy, anti-platelet therapy, or have a history of bleeding disorders
- Used over-the-counter wrinkle products (e.g., alpha-hydroxy acids) or prescription treatments (e.g., Renova, Retin-A, microdermabrasion, chemical peels) in the facial area within 4 weeks prior to study start. In addition, participants will be restricted from using over-the-counter wrinkle products or prescription treatments to the facial area for the duration of the study.
- Have received any investigational product within 30 days prior to study enrollment or are planning to receive other investigational products during the study
Contacts and Locations| Canada, Ontario | |
| Maple Leaf Medical Clinic | |
| Toronto, Ontario, Canada, M5B 1L6 | |
| Principal Investigator: | Mona Loutfy, MD, FRCP(C) | Canadian Immunodeficiency Research Collaborative |
More Information
No publications provided
| Responsible Party: | Canadian Immunodeficiency Research Collaborative |
| ClinicalTrials.gov Identifier: | NCT00333684 History of Changes |
| Other Study ID Numbers: | LA-BA-001 |
| Study First Received: | June 2, 2006 |
| Last Updated: | June 4, 2012 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Facies Immunologic Deficiency Syndromes Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Disease Attributes Pathologic Processes Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on October 16, 2012
